25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CONKLUSION
FDA UDI
SIGNUS Medizintechnik GmbH·04047844006818·The CONKLUSION Pedicle Screw System is a spinal...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002783·X-Large Bur Hole Plate
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551044864·BALL ENDED TORQUE DRIVER BIT, FOR 1201-7 PRECIS...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319719985·Russian Tissue Forceps 8" (20cm)
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SIEMENS INFINITY SC 6002XL MODIFICATIONS
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 23, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 4, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 18, 2023
Widex
FDA UDI
Widex A/S·05706069572643·Widex UNIQUE U-FA 440 DEMO (Winter silver ) Tel...
RETRACTOR BODY
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GAD·September 1, 2020
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
IMED GEMINI PC-2
FDA Adverse Event
Malfunction
·IMED CORP.·Product code FRN·June 23, 1997
PLEX ELITE 9000 SS-OCT
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC, INC.·Product code OBO·October 16, 2018
SPEEDBAND SUPERVIEW SUPER 7?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FHN·May 20, 2013
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 25, 2014
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2011
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
FDA Enforcement
Class III
·Terminated·Impact Instrumentation, Inc.·September 26, 2012