16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPINAL ELEMENTS CERCLAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Support cushion comfort Breast BI 7
FDA UDI
Noras MRI products GmbH·04251269207013·The support cushion serves as a comfortable res...
Support cushion comfort Breast
FDA UDI
Noras MRI products GmbH·04251269206931·The support cushion serves as a comfortable res...
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201770·Endoscopy Basic Procedure Kit
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197031981·KNAPP iris scissors, curved, blunt
10.5cm
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HELENA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 16, 2003
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 2, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 22, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 25, 2022
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 25, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·June 6, 2011
INSERTION DEVICE FOR ZERO-P VA
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVE·April 24, 2020
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015