26 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHALLENGE-EVER
FDA 510(k)
FDA Class 1
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304447127·
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664008581·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...
Zemits YAGenix
FDA UDI
Advance-Esthetic LLC·00860013757533·
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO1022230·Trial, Bi-Convex,10 x 34mm, 12mm
EPIC SPO2 FINGER SENSOR, MODEL E412-20
FDA 510(k)
FDA Class 2
·Cardiovascular
CG-2211 SELFCHECK ECG TRANSMITTER
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·March 29, 2023
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 27, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
CLINICAL INFORMATION CENTER
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DSI·May 19, 2011
UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·ABBOTT SPINE, INC.·Product code HXX·August 7, 2008
GORE-TEX® SUTURE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code GAW·February 10, 2026
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 11, 2025
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021