28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CervAlign Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270664·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694044998·SmartFlex Spring - Small - 6N
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197032278·Jacobson Micro Coronary Scissors
165mm/...
REPROCESSED HARMONIC SCALPEL
FDA 510(k)
FDA Unclassified
·Unknown
ARTHREX TIBIAL GRAFTBOLT
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·June 21, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 28, 2011
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
OSS REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·August 19, 2022
OSS TIBIAL POLY BEARING 20MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 19, 2022
OSS RS POLY FEM BUSHINGS SET/2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·August 19, 2022
QD KNEE BUSHING SET
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 29, 2022
OSS POLY LOCK PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 19, 2022