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

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Prelude IDeal 9F Hydrophilic Sheath Introducer

FDA 510(k)
FDA Class 2 ·Cardiovascular

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM

Resolve® Ceramic

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

Resolve® Ceramic

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

Resolve® Ceramic

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

CERCON HT

FDA 510(k)
FDA Class 2 ·Dental

DS30 HCY BLOOD COLLECTION TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ONE TOUCH BASIC

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 17, 2003

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

MPS2 CONSOLE

FDA Adverse Event
Malfunction ·QUEST MEDICAL, INC.·Product code DTR·February 7, 2025

GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC.·Product code PZE·December 2, 2021

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

VACUUM BOTTLE

FDA Adverse Event
Malfunction ·HOSPIRA·Product code KDQ·August 10, 2011

PROGRASP FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2013

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025