16 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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NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776399221·Buck Femoral Cement Restrictor Inserter 14"
BUCK
FDA UDI
Smith & Nephew, Inc.·03596010041968·BUCK FEMORAL CEMENT RESTRICTOR INSERTER
ProLift
FDA UDI
Life Spine, Inc.·00190837116545·
ProLift
FDA UDI
Life Spine, Inc.·00190837093303·
ProLift Lateral
FDA UDI
Life Spine, Inc.·00190837104641·
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
WUNDER TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Gibralt
FDA UDI
Choice Spine, LP·00840996169455·GIBRALT,DRILL,FIXED,2.4X28
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
UNK MEDTRONIC DUREPAIR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code GXQ·May 14, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
PENCAN SPINAL NEEDLE TRAY
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code BSP·May 24, 2011
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