15 results · 32ms · Sources: EU EUDAMED, 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