16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982151810·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM
FAC-4 - Miller & Long Concrete
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121079·FAC-4 - Miller & Long Concrete
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
FDA 510(k)
FDA Unclassified
·Unknown
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·February 9, 2017
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Other
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009
BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 12, 2017
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 24, 2008
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·August 15, 2011
COULTER® ACT DIFF 2? ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 8, 2013
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code NHA·July 21, 2017
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 16, 2019
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Injury
·LIVANOVA DEUTSCHLAND·Product code DWC·September 21, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025