9 results
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19ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Afikim Electric Vehicles (S.A.E. AFIKIM)
FDA registration
Afikim Electric Vehicles (S.A.E. AFIKIM)·2 products·🇮🇱 Israel
UNIGRAFT
FDA 510(k)
FDA Class 2
·Dental
ULTRASOUND SCANNER, TYPE 1101
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2013
FUSION OMNI-TOME SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·February 25, 2011
CONTAK RENEWAL 2
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
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