10,000 results
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82ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Precision AI Surgical Planning System (PAI-SPS)
FDA 510(k)
FDA Class 2
·Orthopedic
Annalise Enterprise CXR Triage Trauma
FDA 510(k)
FDA Class 2
·Radiology
Annalise Enterprise CTB Triage Trauma
FDA 510(k)
FDA Class 2
·Radiology
Annalise Enterprise CTB Triage Trauma
FDA 510(k)
FDA Class 2
·Radiology
Better Diagnostics Caries Assist (BDCA) Version 1.0
FDA 510(k)
FDA Class 2
·Radiology
Annalise Enterprise CTB Triage Trauma
FDA 510(k)
FDA Class 2
·Radiology
HealthFLD
FDA 510(k)
FDA Class 2
·Radiology
CEPHX- Cephalometric Analysis Software
FDA 510(k)
FDA Class 2
·Radiology
Annalise Enterprise CTB Triage-OH
FDA 510(k)
FDA Class 2
·Radiology
FITC ANTI-RABIES MONOCLONAL GLOBULIN
FDA 510(k)
FDA Class 2
·Microbiology
LIGHT DIAGNOSTICS RABIES DFA REAGENT
FDA 510(k)
FDA Class 2
·Microbiology
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
FDA 510(k)
FDA Class 2
·Hematology
GI Genius
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EFAI ChestSuite XR Pneumothorax Assessment System
FDA 510(k)
FDA Class 2
·Radiology
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
FDA 510(k)
FDA Class 2
·Radiology
ONE STEP HCG PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
FDA 510(k)
FDA Class 2
·Radiology
GI Genius System 100 and GI Genius System 200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology