17 results
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30ms
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Sources: EU EUDAMED, US FDA
LANCE BLADES & SCALPELS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8440011·The DD cubeY® HL zirconium dioxide milling blan...
Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436122266·Sterile transvaginal needle guide for use with ...
RYDERS
FDA UDI
FGX INTERNATIONAL INC.·00772956423010·
KLIGLER IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIVANTAGE DH
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·May 2, 2023
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·November 23, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 12, 2015
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM·Product code DXT·December 9, 2024
OPTIVANTAGE DH
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·January 26, 2024
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM·Product code DXT·November 6, 2024
OPTIVANTAGE DH
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·October 24, 2022
OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM·Product code IZQ·March 12, 2025
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018
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