15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELAN 4 Tools
FDA 510(k)
FDA Class 2
·Neurology
Cavitron®
FDA UDI
Dentsply Professional·D00381832031·Cavitron® Steri-Mate® 360, 3 Pack, G1000 30K De...
ELMED
FDA UDI
ELMED INCORPORATED·00842180185470·RENAL VEIN FIXED RETRACTOR, 1" X 4.5"
THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075115·THERMOPLASTIC INSTRUMENT TRAY
SONY LMD-2451MT LCD MONITOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 18, 2004
OT ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·June 5, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 12, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 26, 2024
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 3, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013
DISPOSABLE SUTURE PLACEMENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code GCJ·July 28, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 30, 2015
ITREL 4
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 10, 2017