11 results
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19ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154572466·SCREWDISC,UN1,SELF-TAPPING,1.5x4mm,80PK
CUSTOM HEALTHCARE SYSTEMS, INC
FDA UDI
Manus Medical, LLC·00811870034305·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111233166·SB GRAVES SPEC LRG W/O TB
DAHLBERG MODEL LG BTE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·November 17, 2010
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 6, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 7, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023