25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tryptik Ti
FDA 510(k)
FDA Class 2
·Orthopedic
Lapidus Trial
FDA UDI
Treace Medical Concepts, Inc.·00810111224086·TMC Lapidus Trial, 9mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006484·1.6mm Pilot Drill, 6mm Stop, Osteopower
OsteoMed
FDA UDI
OSTEOMED LLC·00845694011044·1.8mm Pilot Drill, OSTEOPOWER
ELMED
FDA UDI
ELMED INCORPORATED·00842180171336·2MM DIA., 150MM (6") VERESS INSUFLATION NEEDLE
VARELISA SM ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
ULTIMA SNORING MIKE, MODEL 0540
FDA 510(k)
FDA Class 2
·Anesthesiology
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 22, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 19, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 19, 2023
BIOLOX DELTA HEAD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code LZO·December 12, 2025
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 13, 2013
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 25, 2020
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 1, 2013
I-STAT TROPONIN (HS-TNI ) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code MMI·April 1, 2026
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 26, 2012
HUMAPEN ERGO, BURGUNDY CLEAR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code FMF·July 30, 2015
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 1, 2022