15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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