87 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clear Vinyl Powder-free Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Mini Port
FDA UDI
Covidien LP·20884521066318·Sleeve
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.·00841690191711·Modular Tibia Impactor Pad (Blue)
SR PIP
FDA UDI
Stryker GmbH·00886385019765·SIZE 3: PIP PROXIMAL TRIAL
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650466·
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
COCHLEAR BAHA IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 20, 2016
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·April 28, 2016
BIA400 IMPLANT 4MM W ABUTMENT 12MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·October 11, 2016
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 26, 2016
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·May 25, 2016
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026
BIA400 IMPLANT 4MM WITH ABUTMENT 12MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 6, 2016
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 21, 2016
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025