10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
7950 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020433·7950 PED LG M/F MASK W/1420A
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025