11 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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VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
FDA 510(k)
FDA Class 2
·Orthopedic
Premium Plus CEEA
FDA UDI
Covidien LP·10884523006582·Circular Stapler
MAXCUT CARBIDE BUR (100/pk) FGSS 6
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119831·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
PREMIUM PLUS CEEA*21 INST W/O TILT-TOP*
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 3, 2016
CRITICAL CARE ASSESSMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
INSIGHT GENESIS
FDA 510(k)
FDA Class 2
·Neurology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING 7MM
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·June 2, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·August 12, 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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025