13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
FDA 510(k)
FDA Class 2
·Cardiovascular
EarQ
FDA UDI
Oticon A/S·05707131341983·G10, BTE 13 PP 2.4G 105 C090 EARQ
TELIO CS INLAY & TELIO CS ONLAY
FDA 510(k)
FDA Class 2
·Dental
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021
MIRU 1DAY UPSIDE (MIDAFILCON A)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·January 22, 2025
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·October 7, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
FREESTYLE LIBRE 14 DAY
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023
FREE STYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022
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
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019