14 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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NANOFUSE DBM
FDA 510(k)
FDA Class 2
·Orthopedic
Preat
FDA UDI
Preat Corporation·00842092138892·Equator Abutment For MegaGen AnyRidge x 5mm
LACTOSORB* 2.0MM SYSTEM TEMPLATE
FDA UDI
BIOMET MICROFIXATION, INC·00841036078089·
SINGLEY TUTTLE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076587·SINGLEY TUTTLE FORCEPS SERRATED TIP
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMERICAN BANTEX, MODEL MS 3
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KOD·May 26, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
C-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 24, 2020
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
Allegiance Laminated Wood Crutches, item 74151-050, Child - 28'' - 36''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China
FDA Recall
Terminated
·Duro-Med Industries, Inc.·Product code IPR·August 4, 2004
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