20 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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CDI Blood Parameter Monitoring System 550
FDA 510(k)
FDA Class 2
·Cardiovascular
Monoject
FDA UDI
Cardinal Health, Inc.·10884521544628·Hypodermic Safety Needle
Monoject
FDA UDI
Cardinal Health 200, LLC·10192253025002·Hypodermic Safety Needle 21G x 1" (0.8 x 25 mm)
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493932993·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651932997·HYH,EP TRY,S-SHOT,-,-,10
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18032568866056·GOTFRIED PC.C.P. NECK SCREW - 110 MM
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513103·
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189110001·IN-OVATION® R TGO 020X028 UL/5-5 CS-BC HK
DRILL BIT
FDA UDI
Biomet Orthopedics, LLC·00887868022524·
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18033509850554·GOTFRIED PC.C.P. NECK SCREW - 110 MM STERILE
DUAL SYRINGE HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
FDA 510(k)
FDA Class 1
·Physical Medicine
MONOJECT
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMI·July 23, 2025
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·May 29, 2020
REDIGUT
FDA Adverse Event
Injury
·SUTURES INDIA PVT. LTD.·Product code GAL·October 14, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 21, 2013
CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·June 23, 2011
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020