47 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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POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AF541
FDA UDI
Respironics, Inc.·00606959024434·AF541 Mask with Entrainment Elbow, Leak 1, with...
Apollo
FDA UDI
MEDLINE INDUSTRIES, INC.·00818614022130·Drill 6.5mm
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981030032·PRECONTOURED ROD, 5.5 x 65mm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111279812·LISTON AMP KNIFE 12"(7" BLADE)
Vitale™
FDA UDI
Merit Medical Systems, Inc.·00884450411452·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197038560·Super-Cut Kilner (Ragnell) Scissors
slight...
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
CUSTOM PROXIMAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code JWH·January 8, 2015
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code MXC·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
FLO-GARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011
CUSTOM DISTAL FEMORAL IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
UNK- NON- STANMORE HIP REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code KRO·June 25, 2015