18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex NanoScope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042434·Asian 4 Bicuspid Extraction
SCREW EXTRACTOR SIZE 4 - 9 MM
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code HSB·June 11, 2021
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SCREW EXTRACTOR SIZE 4 - 9 MM
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code HSB·February 23, 2021
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 3, 2008
PRIME BIG WHEEL STRETCHER,30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 26, 2013
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·July 22, 2011
GALAXY G3 6MM X 20CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 XSFT 3MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 8MM X 24CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 7MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 6MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 6MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
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