16 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JKH Stimulator Plus
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III
ZenFlex
FDA UDI
Kerr Corporation·00195062029820·Rotary Files
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100974·DESMARRES LID RETRACTOR #2
mambo™ modular cervical plate system
FDA UDI
Ulrich GmbH & Co. KG·04052536008186·mambo caudal plate M green
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·March 9, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 29, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX
FDA Adverse Event
Death
·ATRICURE, INC.·Product code OCL·November 13, 2018
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 10, 2012
ALYTE V-MESH GRAFT
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTO·June 14, 2013
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 7, 2011
HT50 VENTILATOR
FDA Adverse Event
Malfunction
·FLIGHT MEDICAL LTD.·Product code CBK·July 15, 2008
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024