12 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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LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362104·Integra® Miltex® Westcott Tenotomy Scissors, 5-...
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 21, 2013
ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 44
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·March 9, 2021
ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·November 8, 2022
EPIQ 7C ULTRASOUND CHINA LOCAL
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND (SHANGHAI) CO., LTD·Product code IYN·June 2, 2023
DEKA MOTUS AY
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019
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