10 results · 27ms · Sources: EU EUDAMED, 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