16 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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