16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Angle Handpiece, Surgical Straight Handpiece
FDA 510(k)
FDA Class 2
·Dental
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595316·TRIAL 2171155 O25 IB 20MM 6 DEG 8X55
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000878283·TRIAL 2171155 O25 IB 20MM 6 DEG 8X55
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511062·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111123467·JOHNS HOPKINS FCP STR 5 1/2"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045674·PrimaLIF LLIF PEEK Implant, 11mm X 26mm X 55mm,...
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
AURADORM (NEUROMUSCULAR SLEEP)
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 14, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011
VECTRA GENISYS 2CHG COMBO
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IMG·September 23, 2008
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·January 26, 2026
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018