17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PULSE
FDA UDI
Nuvasive, Inc.·00195377153975·PULSE Extension Arm, Long
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
THERMOFLEX SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Injury
·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·March 15, 2011
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012