34 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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O2Vent W
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
KEY SURGICAL, INC.·10849771049569·K-Wires, Single trocar, Threaded, .062-inch (1....
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012962·K-Wires, Single trocar, Threaded, .062-inch (1....
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
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191728·Revision Tibia Impactor Pad (Green)
SR PIP
FDA UDI
Stryker GmbH·00886385019758·SIZE 2: PIP PROXIMAL TRIAL
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650459·
AAP CANNULATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·September 5, 2019
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 14, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 21, 2011
ULTRAFLEX COVERED NG ESOPHAGEAL STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code ESW·September 17, 2008
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 3, 2025
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code FRN·June 30, 2020
Alaris Pump Module Model 8100
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code FRN·June 30, 2020
CareFusion Alaris Pump Module, Model 8100
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 4, 2020