10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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