13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
FDA 510(k)
FDA Class 2
·General Hospital
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
Ball-End Hex Wrench
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199005850·
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
FDA 510(k)
FDA Class 2
·Cardiovascular
NEOSALUS CREAM
FDA 510(k)
FDA Unclassified
·Unknown
EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code JXG·June 27, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 7, 2013
MERIT HYDROPHILIC COATED GUIDE WIRE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·October 29, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 19, 2024
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·May 1, 2024
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021