9 results · 19ms · Sources: EU EUDAMED, US FDA

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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