16 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHILL Model R
FDA 510(k)
FDA Class 2
·Physical Medicine
devemed
FDA UDI
devemed GmbH·04061644023684·Suction cannula Ø 6.0mm | 17.3cm
with hole
fron...
Reicodent
FDA UDI
devemed GmbH·04061644050000·Suction cannula Ø 6.0mm | 17.3cm
with hole
fron...
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
FDA 510(k)
FDA Class 2
·General Hospital
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
TARGETING ARM PROX. LAT TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
8CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 23, 2013
S-ROM*STM STD,36NK,14X09X130
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 15, 2013
S-ROM*SLEEVE PRX ZTT, 14B-SML
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 15, 2013
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 23, 2012
BIOMET CRUCIATE TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 20, 2017
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 23, 2012
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025