13 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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Microlife Upper Arm Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Mueller First Aid Sport Kit
FDA UDI
Mueller Sports Medicine, Inc.·00074676207384·FIRST AID SPORT KIT
LFI-IN PLACE PLATE BENDER
FDA UDI
W.H. Holden, Inc.·D9282007380·
WHEELCHAIR, MODELS H001A, 4422
FDA 510(k)
FDA Class 1
·Physical Medicine
AVITA BF1 (VITALIO) BODY FAT ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 20, 2015
LOCKING NAIL
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 2, 2007
PRIDE MOBILITY PRODUCTS
FDA Adverse Event
Injury
·PRIDE MOBILITY PRODUCTS·Product code INO·August 11, 2011
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·October 24, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 1, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 20, 2015
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021