10 results · 18ms · 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.

HEMACOUNT WRIGHT GIEMSA STAIN PACK

FDA 510(k)
FDA Class 2 ·Radiology

SB2 - City of Richmond

FDA UDI
Certified Safety Manufacturing, Inc.·00766588226026·SB2 - City of Richmond

Obtura Spartan

FDA UDI
Young Innovations, Inc.·00843471100295·Gutta-Percha, Pellets

Legacy

FDA UDI
Gc Orthodontics America Inc.·E53582260200001·LEGACY 1. MOLAR UPR LFT SZ 02

NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS

FDA 510(k)
FDA Class 2 ·Dental

DRX3000

FDA 510(k)
FDA Class 2 ·Physical Medicine

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

LEOPARD IMPLANT 5? LORDOTIC, 12MM

FDA Adverse Event
Malfunction ·DEPUY RAYNHAM·Product code MQP·November 7, 2012

BECKER EDMS II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code GWM·June 5, 2015

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