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

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KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT

FDA 510(k)
FDA Class 2 ·Orthopedic

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546246·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546239·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546192·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546185·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546208·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546215·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033546222·

TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

FDA Adverse Event
Death ·BECTON DICKINSON·Product code FOZ·April 1, 2016

DATA MANAGEMENT HARDWARE

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 10, 2011

MEVATRON KDS-2

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS·Product code IYE·March 12, 2008

UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

FDA Adverse Event
Injury ·BECTON DICKINSON·Product code FOZ·March 4, 2016

TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·September 10, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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