13 results
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18ms
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Sources: EU EUDAMED, US FDA
WALPEO TABLH
FDA 510(k)
FDA Class 1
·Physical Medicine
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292947·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049323·K-Wires, Double diamond, .045-inch (1.1mm) diam...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484498·K-Wire w. double end lanzet point _x000D_...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189923·TAPERED TIBIAL TRAY DRILL
K-Wire w. double end lanzet point 1.1mm/102mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712020·K-Wire w. double end lanzet point
1.1mm/...
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQUA-SEAL
FDA 510(k)
FDA Class 2
·General Hospital
PROSTHESIS, INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·April 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 3, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 18, 2008
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·July 19, 2017
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025