8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AURORA LED SERIES SURGICAL LIGHTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STRAUMANN GBR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ENRHYTHM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011
PRECISION
FDA Adverse Event
Malfunction
·ADVANCED SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 9, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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