18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
FDA 510(k)
FDA Class 2
·Immunology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306823893·Baby Gerzog Mallet, 172 grams, 0.75" OD, 16.5cm
Z3 GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
SFS SPINAL FIXATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code MNH·April 11, 2017
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 16, 2013
NATURAL KNEE IDE PATELLA SZI
FDA Adverse Event
Injury
·INTERMEDICS ORTHOPEDICS, INC.·Product code HTG·November 12, 1996
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code MIH·October 30, 2012
BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 24, 2023
CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 27, 2014
TURBOHAWK
FDA Adverse Event
Malfunction
·EV3·Product code MCW·August 5, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
VISCOAT
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·September 23, 2012
VISCOAT
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·September 23, 2012
VISCOAT
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·September 23, 2012
VISCOAT
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·September 23, 2012
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020