13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304232266·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515066205·Petit Point Mixter Fcps, 5 1/4"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515019669·Petit Point Mixter Fcps, 5 1/4"
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
FDA 510(k)
FDA Class 2
·General Hospital
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019
SCREWDRIVERS
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HXX·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017