15 results · 23ms · Sources: EU EUDAMED, US FDA

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JULIET LL

FDA 510(k)
FDA Class 2 ·Orthopedic

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052015855·Full Radius Resector 3,5

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046459·PrimaLIF LLIF PEEK Implant, 11mm X 26mm X 35mm,...

ONE TOUCH PROFILE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·February 25, 2002

VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES

FDA 510(k)
FDA Class 2 ·Orthopedic

POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)

FDA 510(k)
FDA Class 1 ·General Hospital

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CGA·October 12, 1999

VIDAS HCG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·June 22, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 9, 2022

VIDAS TSH

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

VIDAS HCG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019