20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471183797·K-WIRE - SINGLE TROCAR 1.8mm DIA x 150mm
RAYSTATION
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
FDA 510(k)
FDA Class 2
·Orthopedic
NRG KNEE P/S NRG BEARING INSERT SIZE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·February 4, 2013
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·December 22, 2010
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·July 17, 2014
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 20X120
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·November 21, 2016
MAXIM KNEE SYSTEM -FML AUG BLT 65X10ML/LR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
AGC TOTAL KNEE PROSTHESIS - INTLK FMRL 65 RT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
OFFSET TIBIAL TRAY - ILOK STEM TIB TRAY 71MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBV·March 22, 2017
MAXIM KNEE SYSTEM - FML AUG BLT 65X10MR/LL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BIOMET TIB BLOCK 10MM 71
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
MAXIM KNEE SYSTEM - FMRL AUG BLT 65X6MR/LL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - MAX ILK ANA CON FMRL 65L RFVII
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
BIOMET COBALT-CHROME FEMORAL COMPONENTS - 28MM MOD HD STD NECK TP1 TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·March 22, 2017
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS - BIOMET HIP FRACTURE FMRL 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·March 22, 2017
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 18X120
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
MAXIM KNEE SYSTEM - FMRL AUG BLT 65X6ML/LR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015