51 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diazyme 1,5-AG Assay
FDA 510(k)
FDA Class 2
·Hematology
BALANCE MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304446458·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034159·Profile Zero 2 X 4 Hole Quad Plate
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158214477·FORCEPS SPLINTER SERRATED 3.5"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694065788·Profile 0 2 x 4 Hole Quad Plate Sterile Qty 5
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 15, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 15, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 13, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 28, 2020
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 21, 2020
POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code HWE·November 30, 2010
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·February 9, 2018
COULTER® HMX AL HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 27, 2011
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·June 13, 2013
LEGEND XT 4CH COMBO PKG
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IPF·September 29, 2008
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 29, 2021