36 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
EliteVue otoscope set, LED, 3.5V, with C-handle
FDA UDI
Rudolf Riester GmbH·04045396209817·The Riester otoscope is produced for illuminati...
LISTER BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054486·LISTER BANDAGE SCISSORS POWER CUT GOLD
Length Gage
FDA UDI
Treace Medical Concepts, Inc.·00810111222877·Length Gage
ELMED
FDA UDI
ELMED INCORPORATED·00842180175679·NEEDLE EXTENDER 3"
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK, KANAMYCIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
PADPRO MODEL #2516
FDA 510(k)
FDA Class 3
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 21, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 17, 2020
SCREW IMPLANT 2-P L 12MM, DIAM. 4.1MM
FDA Adverse Event
Other
·*·Product code DZE·May 19, 2006
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 28, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 21, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
BIO-TRANSFIX, 5MM X 40MM, LONG
FDA Adverse Event
Other
·ARTHREX, INC.·Product code MNU·October 6, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 1, 2013
Brilliance iCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 1, 2017
XODUS MEDICAL
FDA Adverse Event
Malfunction
·XODUS MEDICAL·Product code LYV·June 19, 2020
CADD-LEGACY 1 AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·June 2, 2022