10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDICAL GLOVE SERIES
FDA 510(k)
FDA Class 1
·General Hospital
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20721451·Arch wires Titanol Cosmetic coated mand. .018"x...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022532·
MICROPLEX COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
FDA 510(k)
FDA Class 2
·Cardiovascular
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·April 28, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·April 16, 2025
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