11 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GUT SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUALA DENTAL PRODUCTS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011
ACE
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010
STERILE PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
FDA 510(k)
FDA Class 1
·Physical Medicine
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 19, 2014
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 4, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; 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