15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biodegradable Nitrile Powder Free Examination Glove (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
TWINFIX PK FP SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
UNIMAX SUCTION IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·May 28, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
BIOTENE
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS INC/ORATECH LLC·Product code LFD·October 16, 2019
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·August 25, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 3, 2021
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Injury
·COOK INC·Product code LQR·January 8, 2025
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Injury
·COOK INC·Product code LQR·February 10, 2022
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