29 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Klockner Vega TiBase for CEREC
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776399115·Flexible grasper, double action, 7fr, 35cm, sim...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696363·Dynamic Dental Implant Ø6mm L6mm
ELMED
FDA UDI
ELMED INCORPORATED·00842180137448·BIOPSY CUP SERRATED FLEXIBLE 7 fr
LEONE SPA
FDA UDI
LEONE SPA·08033707018094·CALIBRA 1ST MOLAR BANDS n.LL 22
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190097·Back table tibial tray assembler 4-7
SPECIAL EVD 10-110 W/O Y SITE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·November 1, 2017
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
FDA 510(k)
FDA Class 2
·Dental
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·July 15, 2011
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·June 14, 2013