16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
FDA 510(k)
FDA Class 2
·General Hospital
ADULT DUAL HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 23, 2010
TraXis®
FDA UDI
ZIMMER SPINE, INC.·00889024332836·
TraXis®
FDA UDI
ZIMMER SPINE, INC.·00889024332959·
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BAYER ADVIA IMS SYSTEM; 200 + 3
FDA 510(k)
FDA Class 2
·Immunology
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 21, 2010
ADULT DUAL HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 2, 2011
TraXis Vue Spinal Implant System, Part #2601-090921
FDA Recall
Terminated
·Abbott Spine·Product code MQP·November 2, 2005
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
Medshape Universal Joints, REF: DNE-9000-UJ
FDA Enforcement
Class II
·Ongoing·Medshape, INC.·September 10, 2025
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022