10 results · 27ms · Sources: EU EUDAMED, US FDA

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O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)

FDA 510(k)
FDA Class 2 ·Anesthesiology

NEPTUNE WASTE MANAGEMENT STSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ZAP DUAL CURING LIGHT

FDA 510(k)
FDA Class 2 ·Dental

CONVEEN CONTOUR LEG BAG

FDA Adverse Event
Malfunction ·COLOPLAST CORPORATION·Product code FAQ·October 7, 2014

HEALON DUET

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code LZP·May 3, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

EON RECHARGEABLE IPG, 16-CHANNEL

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·April 14, 2011

BITS, DRILL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·November 1, 2019

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

FDA Enforcement
Class II ·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014

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