16 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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Westmed Gas Sampling Cannula with O2 delivery
FDA 510(k)
FDA Class 2
·Anesthesiology
Truline
FDA UDI
Arbill Industries, Inc.·00850052602420·Made in Malaysia. Black disposable nitrile. Si...
Truline
FDA UDI
Arbill Industries, Inc.·10850052602144·
Bi-Metric® Revision Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868261329·
BI-METRIC REVISION HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304006997·
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307353·
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRANDIO FLOW TRY-IN
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
RESURFACING FEMORAL HEAD 54MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KXA·September 28, 2017
COBAS 6000 CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 8, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
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