22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLADE SEPTOSTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
inomed Medizintechnik GmbH·04250307610334·U-shaped base for vertical arc support
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D9098010301·SUPER GLASS MIRROR - OCCLUSAL
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111695·
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377023163·NOMAD Disposable Sensor Pack
Zavation
FDA UDI
Zavation LLC·00842166178533·Set of blades 130mm lateral
Zavation
FDA UDI
Zavation LLC·00842166178496·Set of blades 90mm lateral
Zavation
FDA UDI
Zavation LLC·00842166178526·Blades Titane
Zavation
FDA UDI
Zavation LLC·00842166178540·Blades Titane
Zavation
FDA UDI
Zavation LLC·00842166178564·Blades Titane
Zavation
FDA UDI
Zavation LLC·00842166178557·Blades Titane
Zavation
FDA UDI
Zavation LLC·00842166178502·Set of blades 100mm lateral
Zavation
FDA UDI
Zavation LLC·00842166178519·Set of blades 110mm lateral
URANUS, COMFORTOUCH LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020