20 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AURIGA XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664114756·ANTI-EMB STOCKINGS KNEE HIGH CLOSED TOE LARGE-L...
MAXCUT CARBIDE BUR (10/pk) FGSS 700
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114751·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033788·Coupling Treatment Tube for 5F Flexibles (15)
Drill Bit
FDA UDI
Jeil Medical Corporation·08800089476374·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776404963·Matzenauer Vaginal Spec 4-5/16"x1" OA 12-3/8"
COMPRESS ANTI-ROTATION SPINDLES
FDA 510(k)
FDA Class 3
·Orthopedic
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
FDA 510(k)
FDA Class 2
·General Hospital
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 14, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
PREMILENE 3/0 (2) 75CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019
CPS TIB SPINDLE LT 12X37X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025