12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AI Platform (AIP001)
FDA 510(k)
FDA Class 2
·Radiology
36M - City of Gastonia - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588025018·36M - City of Gastonia - Metal
Sklar®
FDA UDI
SKLAR CORPORATION·10649111351242·SKLARLITE XD HARTMANN CVD 3.5"
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277103420·Meniscus Rasp 2.7 Cutting 15 Degrees Down
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019
Quantib Prostate
FDA 510(k)
FDA Class 2
·Radiology
MAXTER STERILE POWDER FREE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
KENSTONE METAL·Product code INP·September 2, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023