11 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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Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
FDA 510(k)
FDA Class 1
·General Hospital
NEXT Coarse Strawberry Prophy Paste Box 200
FDA UDI
Preventech·D024220373·NEXT Coarse Strawberry Prophy Paste Box of 200 ...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134217·LATERAL,COBB DISSECTOR,ANGLED
INSORB ABSORBALBE STAPLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Deltaven Fast Flash Closed I.V. Catheter Systems
FDA 510(k)
FDA Class 2
·General Hospital
CONSEPT 1 STEP NEUTRALIZING TABLET
FDA Adverse Event
Malfunction
·ADVANCED MEDICAL OPTICS, INC.·Product code LPN·October 31, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 23, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
50MM ID US COCR LNR 62MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·November 15, 2018
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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