45 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AXS VECTA 074 CATH 132CM - CE
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024
Tether
FDA UDI
Seaspine Orthopedics Corporation·10889981101695·Fixed Self-Centering Drill 13mm
LISTER BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054523·LISTER BANDAGE SCISSORS POWER CUT GOLD
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165512·DEAVER RETR THIN HANDLE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006309·2.0mm Pilot Drill, Calibrated, Mandible, J-Latch
K-Wire
FDA UDI
Treace Medical Concepts, Inc.·00810111223010·K-Wire
SKINTACT
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·April 8, 2020
VIDAS® CMV IGG ASSAY
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LFZ·October 18, 2019
INTRAORAL CAMERA ME-15
FDA 510(k)
FDA Class 1
·Dental
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 6, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 7, 2023
SC 9000
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SYSTEMS, INC. EM-P·Product code KMI·April 9, 1999
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 7, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 7, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 10, 2023
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·January 10, 2020
AEQUALIS REVERSED FRACTURE
FDA Adverse Event
Injury
·Product code KWS·January 29, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025