15 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACIF Interbody System Instruments
FDA UDI
Tyber Medical, LLC·M695002C1405060·5 Deg 14 mm Dual-Sided Trial, 5 & 6 mm H
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481120909·LOCATOR R-Tx Abutment For UF(II) Narrow Platfor...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704837·Backhaus Towel Clamp 5-1/4" (13.3cm)
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
FDA 510(k)
FDA Class 2
·Anesthesiology
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTP·May 31, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014
ETS-FLEX - ENDOSCOPIC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2011
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·October 8, 2014
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 14, 2016
PRINCESS
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code FAS·July 17, 2020
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 4, 2016
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·June 30, 2006