42 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ArgenZ HT+ 98x30 D4
FDA UDI
ARGEN CORPORATION, THE·D818122126·Dental porcelain/ceramic restoration kit
GENUINE FIRST AID CPR MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 28, 2022
T:SLIM X2, BASAL-IQ, MMOL/L
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 23, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2019
OT ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·July 18, 2019
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL LTD.·Product code KWA·June 3, 2011
MICRA
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code PNJ·February 9, 2017
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 9, 2010
ARROW RA CATH SET: 22 GA X 1-3/8"
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQX·August 2, 2021
ILS 21MM CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018
ETS45 ENDO LINEAR CUTTER 45MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018
ETS-FLEX60 ENDOSCOPIC ARTICULATING LINEAR CUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018
NEU_ENTERRA_INS
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·July 16, 2018
ARROW ARTERIAL CATH SET: 18GA X 12CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·December 4, 2024