15 results · 22ms · Sources: EU EUDAMED, US FDA

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Vaginal Moisturizing Gel

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Extension Tubing

FDA UDI
C. R. Bard, Inc.·00801741050824·Extension Tubing, For use with Male External Ca...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100080·TEMPORAL SPECULUM OPEN WIRE

HNM Women Care

FDA UDI
HNM STAINLESS, LLC.·00812171028123·PESSARY, DISH #2, W/O SUPPORT, 60mm

SYRINGE 20ML LL TIP CONV PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·November 6, 2023

STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000

FDA 510(k)
FDA Class 2 ·Neurology

ARSTASIS ACCESS SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD MULTI-CHECK CD4 LOW CONTROL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

RESTORE SENSOR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

TREVO XP PROVUE 4MM X 30MM

FDA Adverse Event
Injury ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020

BD MULTI-CHECK CD4 LOW CONTROL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

FDA Enforcement
Class II ·Ongoing·CP Medical Inc·April 26, 2017

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024