8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RUBBER CONTRACEPTIVE (CONDOM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
A10 ULTRASCOPE RECORDER
FDA 510(k)
FDA Class 1
·Cardiovascular
GENERAL ELECTRIC AMX II
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·November 10, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 2012
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020