9 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.

MICROBIOLOGY SPECIMEN BRUSH

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MS X-RAY GRID

FDA UDI
MITAYA MANUFACTURING CO., LTD.·04589744208232·432.4x432.4mm,130cm focus,1.22mm thick, 70lines...

MS X-RAY GRID

FDA UDI
MITAYA MANUFACTURING CO., LTD.·04589744208249·432.4x432.4mm,130cm focus,1.46mm thick, 70lines...

ACON ONE STEP DRUG SCREEN TEST CARD

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

SMARTSITE NEEDLE FREE VALVE

FDA Adverse Event
Malfunction ·CAREFUSION CORP·Product code FPA·April 30, 2014

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 6, 2012

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·September 20, 2007

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