13 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
FDA 510(k)
FDA Class 2
·Anesthesiology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177414·VuePoint Cross Conn, 3.5x40mm Fixed Rod
NICOLET WIRELESS EEG
FDA 510(k)
FDA Class 2
·Neurology
CONPHAR CRUTCH GRIPS
FDA 510(k)
FDA Class 1
·Physical Medicine
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
ANEURX
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 30, 2014
ASPHERE M SPEC 11/13 36 +0
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·November 12, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMDOUALTION·Product code LGW·January 2, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024