Today, the top medical device companies in Arizona are made known. Medical devices are classified as I, II, and III.
Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type.
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k), and most Class III devices require Premarket Approval.
A description of device classification and a link to the Product Classification Database is available at “Classification of Medical Devices.”
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies
- Quality System (QS) regulation,
- Labeling requirements, and
- Medical Device Reporting (MDR)[lwptoc]
Medical device companies in Arizona
Below are some of the medical device companies in Arizona;
- Salutaris Medical Devices, Inc.
Medical equipment manufacturer in Catalina Foothills, Arizona
Address: 4340 N Campbell Ave #266, Tucson, AZ 85718, United States
Hours: Open now
Phone: +1 520-638-7518
SalutarisMD® [SMD] is a clinical-stage medical device company. SMD’s BetaCurve is a globally-patented, 510(k)-cleared device designed to treat various ophthalmic diseases with precision beta radiotherapy, including PCV.
The BetaCurve curves around the back of the eye to precisely deliver therapeutic beta radiation to the diseased area using a fiber optic light source for placement guidance.
The procedure is an outpatient, takes 10-minutes, and requires only one treatment. Utilizing a common technique, retina surgeons do not require additional methodological training.
- Vante and SEBRA
Address: 3480 E Britannia Dr #120, Tucson, AZ 85706, United States
Hours: Open 8 Am
Phone: +1 520-881-6555
Vante has been a leader in the global biopharmaceutical manufacturing industry for decades providing sterile connecting and disconnecting solutions.
A pioneer in radio frequency technology, Vante (before 2009 SEBRA) patented the first hand-held RF sealer and is dedicated to the continuous development of innovative technology and quality products and focused on delivering reliability, quality, and service.
Through the re-acquisition of the ZEBRA in 2017, they can expand their product portfolio to give customers a wider range of solutions. This move also increases their ability to develop next-generation offerings to address current and future needs within the industry. their SEBRA products offer a line of quality, reliable, sealers for medical tubing and blood bags and cater to the blood banking industry.
At Vante they know you are in the business of saving lives. They are here to make sure you have reliable equipment to do that.
- Spectrum Plastics Group | Xeridiem Medical Devices
Address: 4700 S Overland Dr, Tucson, AZ 85714, United States
Hours: Opens at 8 am
Phone: +1 520-882-7794
From small, custom-engineered solutions, to large-scale production they have the resources to support your project regardless of scale.
By condensing your supply chain to become your single source partner, it allows them to be the one-stop solution to all your projects’ needs—satisfying unique application and performance needs while maintaining tight, repeatable outcomes.
- Medical Device the USA
Address: 11000 N Scottsdale Rd Suite 135, Scottsdale, AZ 85254, United States
Hours: Open 24 hours
Phone: +1 844-583-0951
This facility is owned by Alyssa Flores, a serial entrepreneur. She is the President / CEO of Scottsdale-based Medical Device USATM, a national distribution company with a focus on medical device sales.
Alyssa’s background started with business and marketing at Fresno State University. While living in California, her career launched in manufacturing, and upon moving to Arizona she fell in love with the banking and finance industries which ultimately led her to CSQ BioTM and the development of Medical Device USATM.
- MedTech AZ
Address: 1016 E Blackhawk Dr, Phoenix, AZ 85024, United States
Hours: Open 8 Am Closes 7 PM
Phone: +1 602-574-2985
MedTech™ has over 40 years of experience in the medical equipment repair/service market. Their service rates are highly competitive and, in many cases, lower than industry standards. They provide sales, service, equipment consultation, equipment refurbishing, and on-site or remote support if needed.
Their repair professionals are located in Phoenix, Arizona; although can accommodate non-local service repair on a case-by-case basis.
In the rare case that MedTech™ cannot provide the services you need, they will do their best to refer you to someone who can.
- Copper Star | Home Medical Supplies | Medical Supply Store
Address: 1155 S Power Rd Ste. 111, Mesa, AZ 85206, United States
Phone: +1 602-609-5554
Copper Star Home Medical is your leading medical supply store in Phoenix AZ. Their team is committed to understanding your concerns, creating a custom solution, and getting you the medical supplies you need for the health and wellness you deserve.
They are committed to being respectful of your time and providing the best products and services. Visit their Store in Phoenix AZ Today.
- C. Medical Inc.
Address: 15002 N 25th Dr #1, Phoenix, AZ 85023, United States
Hours: Open ⋅ Closes 4 PM
Phone: +1 623-780-0700
I.C. Medical is a world leader in the field of surgical smoke collection and evacuation research and development. I.C. Medical manufactures advanced surgical plume collection/evacuation devices used by top surgical teams worldwide.
By maintaining total control over the engineering and production processes, the quality, integrity, and reliability of I.C. Medical’s surgical smoke evacuation devices are never compromised.
I.C. Medical’s surgical smoke evacuation systems and accessories undergo rigorous QA and testing procedures to ensure that they are manufactured to the highest standards.
All products are made with virgin raw materials sourced from reliable suppliers and produced and assembled in a pristine manufacturing environment by a well-trained and highly skilled workforce.
- LCCS Medical Inc.
Address: 16661 N 84th Ave #110, Peoria, AZ 85382, United States
Hours: Open 8 AM Closes 5 PM
Phone: +1 844-743-6449
LCCS Medical Inc. is a privately held company that develops, manufactures, markets, and distributes premium quality specialty medical devices for pain management and regional anesthesia.
Every device is designed precisely for their physician partners to aid in the comfort of patients while also bettering surgical outcomes
LCCS started developing RF pain management and regional anesthesia products in 2009 and entered the U.S. market in 2011.
Their RF Cannulas, RF Electrodes, and Grounding Pads, along with Spinal Needles and Epidural Needles are U.S. FDA approved.
Additionally, the RF Cannula and RF Electrodes are CE marked. They maintain an industry-leading quality system certified to ISO 13485 by TUV Rheinland and fully conform to the U.S. FDA 21 CFR 820. their U.S. headquarters distributes these physician preferred devices to customers nationwide.
LCCS Medical Inc. started developing RF pain management and regional anesthesia products in 2009. They started selling these products to the U.S. market in 2011 through their exclusive nationwide distributors before taking on distribution themselves in 2018. In those eight years, they have had zero FDA incidents.
- DGA MEDICAL
Address: 13236 N 7th St, Phoenix, AZ 85022, United States
Phone: +1 602-583-7698
DGA Medical is committed to connecting the customer with what they want to what they need, at a fair price and knowledgeable service.
Background
DGA Medical is owned and operated by Doug Anderson. Doug has been in the medical equipment industry for over 30 years.
To include field service engineer with a major OEM, supervising a refurbishment line, and sourcing and selling parts for over 15 years.
He has worked on X-ray, Cath Lab, CT, MR, Ultrasound, Trailers, and Modular Buildings. Doug has bought and sold parts for every major OEM in every imaging modality.
LDGA Medical has expanded its offering to include new systems. The company is SAM, Vetbiz, and WAWF registered.
- Hi-Tech Medical Supply & Equipment
Address: 2120 E 6th St, Tempe, AZ 85281, United States
Hours: Opens 8 Am
Their extensive experience includes operating DME programs within ambulatory surgery centers, small specialty surgical hospitals, and physician practices.
Also, their ownership group takes great pride in the team they have in place to work with you and they understand that they must innovate every day to provide their team with the training, skills, processes, and support required to allow them to utilize their unique talents and experience. You will not find a more dedicated team in Phoenix to help you with your post-surgery recovery.
- Optima Surgical
Address: 5028 S Ash Ave #102, Tempe, AZ 85282, United States
Hours: Opens 8 Am
Phone: +1 480-237-4971
Optima Surgical is a leading provider of medical device technologies and media development solutions for spine care physicians and MedTech organizations.
” Their Goal at Optima Surgical is to Help Physicians and Patients Achieve Theirs.”
With headquarters in Tempe, Arizona, Optima Surgical team members currently provide service to physicians and patients throughout the State of Arizona and Northern Nevada.
At Optima Surgical they are committed to continual improvement both individually and as an organization so that they can be an optimal resource and valuable medical device partner to physicians and their patients.
- AAA Ultimate Medical Supply LLC
Address: 1107 E Bell Rd Suite 10, Phoenix, AZ 85022, United States
Hours: Open 8 am Closes 6 PM
Phone: +1 602-978-4100
Ultimate Medical Equipment Inc. has focused on providing quality customer service to people in their time of need.
When a family member is sick, elderly, or post-surgery. When the insurance company is not able to respond quickly enough, Ultimate can sell or rent the equipment you need the same day, 24 hours a day, 7 days a week.
The full line retail store stocks and delivers home and commercial medical equipment, hospital beds, oxygen supplies, wheelchairs, walker aids, knee walkers, braces, supports, incontinent supplies, sports therapy, wound care and so much more.
- Pacific Biomedical
Address: 2443 W 12th St #1, Tempe, AZ 85281, United States
Phone: +1 480-264-3242
Pacific Biomedical is a leader in orthopedic surgery recovery systems and technologies serving Greater Phoenix. Their systems help you recover faster and healthier so you can get back to doing the things you love.
Also, Pacific Biomedical has been providing Durable Medical Equipment (DME) products to patients in the home since 2007 serving over 18,000 Arizona patients. Their experience and focus are on delivering therapeutic modalities to patients for their In-Home recovery after surgery. They serve all of Greater Phoenix, helping patients all over the valley recover after surgery with their in-home therapy systems.
Their 24/7 In-Home Patient Program provides the convenience of home delivery, set-up, and pickup for all Postoperative surgical needs.
We’re a Medicare Accredited facility and Certified by the BOX with over 40 years of Combined Durable Medical Equipment experience.
Consistent ownership has created an environment where team members feel empowered to deliver extraordinary care and they understand their best talents are well represented in their work with Pacific Biomedical.
That feeling of ownership drives long-term retention and a depth of experience that is second to none among DME providers in the state of Arizona. The individuals you interact with are supported by strong processes, focused on continuous improvement, and take tremendous pride in helping you.
Pacific Biomedical is the ideal partner for your healthcare organization and you will benefit from their experience and responsiveness to the needs of your team members and the patients and families you serve.
Frequently Asked Questions about the Medical device companies in Arizona
See below for the perfect answers to the most asked questions about the medical device companies in Arizona;
- What regulations apply to medical devices?
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies.
- What are the three classifications of medical devices?
There are 3 classes of medical devices:
- Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and non-electric wheelchairs.
- Class II devices are intermediate-risk devices.
- Class III devices are high-risk devices that are very important to health or sustaining life.
- Where are most medical device companies located?
California is home to more medical device companies than any other U.S. state, with a dense network of high-tech firms and a talented workforce. But some of the most life-saving (as well as most highly regulated) devices have been created in Minnesota.
- Who regulates the medical device industry?
FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products. In the U.S., FDA regulates the sale of medical device products.
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Chibueze Uchegbu is a certified medical physiologist with a great passion for healthy living.