Device Directory
Browse 238 FDA-cleared medical devices
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358)
Class Class II K221358 OCL
ISAAC Neurovascular Navigation Catheter (K222115)
Class Class II K222115 DQY
INFINITY OCT System (K223764)
Class Class II K223764 NKG
Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181)
Class Class I K222181 LZA
Ideal Med Pro 3-Ply Disposable Face Mask (K221682)
Class Class II K221682 FXX
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle (K203792)
Class Class II K203792 FMI
Implant Direct Dental Implant Systems Portfolio – MR Conditional (K222211)
Class Class II K222211 DZE
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH (K221781)
Class Class II K221781 GCJ
IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) (K221348)
Class Class II K221348 MHX
Insulin syringe with integrated needle DL (K203211)
Class Class II K203211 FMF
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