15 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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Hudson RCI AquaPak Sterile Prefilled Nebulizers
FDA 510(k)
FDA Class 2
·Anesthesiology
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P1530103·PA TAPE SURGICAL CLOTH 1X10YD 12/BX 12BX/CS - (CS)
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
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127988·3.0 X 10mm Cannulated Headless Screw, T10
LEONE SPA
FDA UDI
LEONE SPA·08033707014645·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 10
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORO74001530101·Mini-Mono-Bracket Roth 'N' .018" max. 1 left
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORN74101530101·Mini-Mono-Bracket Roth 'N' .018" max. 1 right
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180526064·REUSABLE JAMSHIDI - LIGHTWEIGHT HANDLE
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISTADENT AT COMPLETE, MODEL 3.1
FDA 510(k)
FDA Class 2
·Radiology
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013
ON-SILVERSOAKER 2.5IN (6.5CM), 270ML X 5ML/HR
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·June 17, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2014
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014