16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ST SENSE NV 8 ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637321·CoRoent Ant TLIF PEEK, 14x10x28mm 12°
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052566·Pratt T- Hemostatic Forceps
150mm, 6"
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 5, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 23, 2015
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 3, 2014
PRIME ZOOM STRETCHER,30"LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
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
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012