16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599093·TRIAL 2190545 O25 IB 27MM 0 DEG 16X45
The MetaNeb®System
FDA UDI
HILL-ROM SERVICES PTE. LTD.·00887761997356·Respiratory Care
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042267·4 Bicuspid Extraction w/Seating Springs
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
FDA 510(k)
FDA Class 2
·Orthopedic
SLEEPRIGHT
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 2, 2008
CVC SET: 3-LUMEN 8.5FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQO·June 21, 2013
CATHETER, TRANSLUMINAL BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GBA·August 4, 2011
GALAXY G3 MINI 1.5MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 24, 2020
GALAXY G3 MINI 2.5MM X 4.5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 29, 2020
MICRUSFRAME10 6MM X 26CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·July 14, 2020
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