16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Collision Check
FDA 510(k)
FDA Class 2
·Radiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595989·TRIAL 2171350 O25 IB 20MM 6 DEG 12X50
Sklar®
FDA UDI
SKLAR CORPORATION·10649111153228·FERGUSON ANGIO FCP 7.5" CVD
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613044800·3K Beaver Style Chuck, Round Handle, Collet Use...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100769·FLIERINGA FIXATION RING 15MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045735·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 50mm,...
RADSCAN EQUIPMENT SLICKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 1, 2022
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 18, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 14, 2013
FOLYSIL SILICONE CATHETER
FDA Adverse Event
Injury
·COLOPLAST MANUFACTURING FRANCE, SAS·Product code KOD·September 22, 2008
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 22, 2023
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