13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tornier Humeral Nail and Tornier Long Humeral Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
SONTEC GELPI RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026513·SONTEC GELPI RETRACTOR MULTIPLE LEVEL PARALLEL ...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020782·INTRG WHISP-Z MBT CUS HK -7T +3A 022 LL
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 13, 2022
Axis Spine Technologies ALIF
FDA 510(k)
FDA Class 2
·Orthopedic
GGM Breathing Circuit Bacterial Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
SPEEDBAND SUPERVIEW SUPER 7 LIGATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 7, 2008
LCS COMP RP INSERT STD+ 12.5MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NJL·September 1, 2011
REAMER F/HIPSCR Ø6.5/4.5 F/AFN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025