27 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROTOLOGY DRAPE, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00270211·
RMO
FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00271021·
OptiMesh 1500 S
FDA UDI
SPINEOLOGY INC.·M7403002702·Surgical Mesh
SUREFIT DISPERSIVE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAIL HANDLE T2 TIBIA
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016
TROCAR, LONG T2 FEMUR
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
VALVE SET, EM2400
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022
Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY KUTIER (1) SCALPEL W/HANDLE 20 (1 i WRAPPER 24 X 24 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
VALVE SET, EM2400
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 13, 2018
TOTALCARE SPORT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 13, 2013
PFC SIGMARP STB TB IN 5 15.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·February 17, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 8, 2008
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
EXACTA-MIX 2400 COMPOUNDING SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023