14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
FDA 510(k)
FDA Class 2
·Dental
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975057037·
UNKNOWN COBLATION DEVICE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·January 30, 2024
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
FDA 510(k)
FDA Class 2
·Dental
EVA DIGITAL DENTAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 13, 2024
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 29, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013
12.4 CM HEAVY DUTY LONG ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 30, 2014
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·April 30, 2025
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019