56 results
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20ms
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Sources: EU EUDAMED, US FDA
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Fda510k
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IMAGE1 GI CCU MODEL 22203020-114
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DISPOS. ACU-CUT SOFT TISSUE BIOPSY
FDA 510(k)ACU-TEST IN-HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACU-MED RED MISER HEMOTHORAX BLOOD COLL.
FDA 510(k)
FDA Class 2
·Anesthesiology
Acu-sInQ Complete Endoscope Cleaning Aid System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
Image1 S CCU, Image1 S 4U Camera Head
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
FDA 510(k)
FDA Class 2
·Ophthalmic
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
FDA 510(k)
FDA Class 2
·Neurology
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology