15 results · 21ms · Sources: EU EUDAMED, 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