10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SciMoCa
FDA 510(k)
FDA Class 2
·Radiology
BD MICROTAINER® TUBES WITH K2E (K2EDTA)
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·October 6, 2022
ECLERIS MICROSTAR COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
FDA 510(k)
FDA Class 2
·Hematology
REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012
THE EMAX 2 PLUS SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE·Product code FKX·June 20, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.
FDA Recall
Terminated
·Arcadia Medical Corporation·Product code BTO·April 18, 2012
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018