22 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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IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Sbo Hearing A/S·05714464058198·OTICON ZIRCON 1 MINIRITE T C091
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361029540·Ø12MM X 80MM HYBRID FUSION SCREW, SACROFUSE
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604376·MOSS 100 Ti Rod, Ø4.5x480mm
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DreamStation 2 System, DreamStation 2 Advanced System
FDA 510(k)
FDA Class 2
·Anesthesiology
SONOTRAX ULTRASONIC POCKET DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
ALT (SGPT) KINETIC METHOD TC MATRIX-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001099·The ALT (SGPT) KINETIC METHOD TC MATRIX-240/480...
AST (SGOT) KINETIC METHOD TC MATRIX-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001167·The AST (SGOT) KINETIC METHOD TC MATRIX-240/480...
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001044·The Alkaline Phosphatase (ALP) Kinetic Method T...
Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001235·Teco Diagnostics BUN (Urea) Reagent Kit TC Matr...
Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001549·Teco Diagnostics Creatinine (Kinetic) Reagent K...
α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480
FDA UDI
TECO DIAGNOSTICS·10673486001136·The α – AMYLASE LIQUID REAGENT (KINETIC METHOD)...
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 30, 2014
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011