Anesthesiology
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- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- DZJDriver, Wire, And Bone Drill, Manual2Product Code
- K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery2Cleared 510(K)
- K242263TECHFIT DISRP® System2Cleared 510(K)
- K231520tmCMF Solution2Cleared 510(K)
- K230276TECHFIT DISRP® System2Cleared 510(K)
- K223024MedCAD AccuPlan System2Cleared 510(K)
- K220366EmbedMed2Cleared 510(K)
- K220648OMF ASP System2Cleared 510(K)
- K212570OsteoPlan System2Cleared 510(K)
- K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) System2Cleared 510(K)
- K193301coDiagnostiX2Cleared 510(K)
- K210347VSP System2Cleared 510(K)
- K193499DigiGuide System2Cleared 510(K)
- K192282MedCAD® AccuPlan® System2Cleared 510(K)
- K181813ImmersiveView Surgical Plan (IVSP®)2Cleared 510(K)
- K192192VSP System2Cleared 510(K)
- K182789KLS Martin Individual Patient Solutions (IPS) Planning System2Cleared 510(K)
- K181241KLS Martin Individual Patient Solutions (IPS) Planning System2Cleared 510(K)
- K172164PROPEL Device2Cleared 510(K)
- K150392PROPEL device2Cleared 510(K)
- K150796Dental Bone Cutting Instruments2Cleared 510(K)
- K133907VSP SYSTEM2Cleared 510(K)
- K120956VSP SYSTEM2Cleared 510(K)
- K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM2Cleared 510(K)
- K943540SURGICAL CUTTING BURS2Cleared 510(K)
- K915848SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.2Cleared 510(K)
- K894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT2Cleared 510(K)
- K894150COUNTERBORE FOR SS SUBMERGED SCREW PLANT2Cleared 510(K)
- K883922TECHMEDICA I.B.O. BLADE2Cleared 510(K)
- K871834DRILL, HAND, BONE, SMEDBERG2Cleared 510(K)
- K781974IMPLANT DRIVERS AND TIPS2Cleared 510(K)
- K760960SURGICAL WIRE DRIVER2Cleared 510(K)
- DZKWire, Fixation, Intraosseous2Product Code
- DZLScrew, Fixation, Intraosseous2Product Code
- DZMNeedle, Dental1Product Code
- DZNInstruments, Dental Hand1Product Code
- DZPInstrument, Diamond, Dental1Product Code
- DYXLock, Wire, And Ligature, Intraoral2Product Code
- DZADrill, Dental, Intraoral1Product Code
- DZHSaw, Bone, Ac-Powered2Product Code
- DZIDrill, Bone, Powered2Product Code
- EAXMirror, Mouth1Product Code
- EAYLight, Fiber Optic, Dental1Product Code
- EAZLight, Operating, Dental1Product Code
- EBALight, Surgical Headlight1Product Code
- EBWController, Foot, Handpiece And Cord1Product Code
- ECBUnit, Syringe, Air And/Or Water1Product Code
- ECPInstrument, Ligature Tucking, Orthodontic1Product Code
- ECQAligner, Bracket, Orthodontic1Product Code
- ECRSetter, Band, Orthodontic1Product Code
- ECSPusher, Band, Orthodontic1Product Code
- ECTDriver, Band, Orthodontic1Product Code
- EFAHandpiece, Belt And/Or Gear Driven, Dental1Product Code
- EFBHandpiece, Air-Powered, Dental1Product Code
- EFKForceps, Articulation Paper1Product Code
- EFLForceps, Dressing, Dental1Product Code
- EGIParallelometer1Product Code
- EGMInjector, Jet, Mechanical-Powered2Product Code
- EGNScissors, Surgical Tissue, Dental1Product Code
- EGQInjector, Jet, Gas-Powered2Product Code
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental1Product Code
- EIBSyringe, Irrigating (Dental)1Product Code
- EICSyringe, Periodontic, Endodontic, Irrigating1Product Code
- EIDSyringe, Restorative And Impression Material1Product Code
- EIFAccessories, Retractor, Dental1Product Code
- EIGRetractor, All Types1Product Code
- EIKCarver, Wax, Dental1Product Code
- EILGauge, Depth, Instrument, Dental1Product Code
- EIRScissors, Collar And Crown1Product Code
- EISRemover, Crown1Product Code
- EIXProbe, Periodontic1Product Code
- EIYInstrument, Filling, Plastic, Dental1Product Code
- EJBHandle, Instrument, Dental1Product Code
- EJYPliers, Operative1Product Code
- EJZKnife, Margin Finishing, Operative1Product Code
- EKAFile, Margin Finishing, Operative1Product Code
- EKBExplorer, Operative1Product Code
- EKCExcavator, Dental, Operative1Product Code
- EKDInstrument, Cutting, Operative1Product Code
- EKECurette, Operative1Product Code
- EKFInstrument, Contouring, Matrix, Operative1Product Code
- EKGCondenser, Amalgam And Foil, Operative1Product Code
- EKHCarver, Dental Amalgam, Operative1Product Code
- EKICarrier, Amalgam, Operative1Product Code
- EKJBurnisher, Operative1Product Code
- EKKSpreader, Pulp Canal Filling Material, Endodontic1Product Code
- EKPReamer, Pulp Canal, Endodontic1Product Code
- EKQPreparer, Root Canal Endodontic1Product Code
- EKRPlugger, Root Canal, Endodontic1Product Code
- EKSFile, Pulp Canal, Endodontic1Product Code
- EKTCurette, Endodontic1Product Code
- EKWBroach, Endodontic1Product Code
- EKXHandpiece, Direct Drive, Ac-Powered1Product Code
- EKYHandpiece, Water-Powered1Product Code
- EKZUnit, Electrosurgical, And Accessories, Dental2Product Code
- ELAInstrument, Hand, Calculus Removal1Product Code
- ELBScaler, Rotary2Product Code
- ELCScaler, Ultrasonic2Product Code
- EMDHemostat, Surgical1Product Code
- EMEPunch, Biopsy, Surgical1Product Code
- EMGForceps, Tooth Extractor, Surgical1Product Code
- EMHForceps, Rongeur, Surgical1Product Code
- EMIFile, Bone, Surgical1Product Code
- EMJElevator, Surgical, Dental1Product Code
- EMKCurette, Surgical, Dental1Product Code
- EMLChisel, Bone, Surgical1Product Code
- EMMChisel, Osteotome, Surgical1Product Code
- EMNScaler, Periodontic1Product Code
- EMOKnife, Periodontic1Product Code
- EMPMarker, Periodontic1Product Code
- EMQHoe, Periodontic1Product Code
- EMRFile, Periodontic1Product Code
- EMSCurette, Periodontic1Product Code
- JEPRetainer, Matrix1Product Code
- JEXPlier, Orthodontic1Product Code
- JEYPlate, Bone2Product Code
- KMWHandpiece, Rotary Bone Cutting2Product Code
- MDLImplant, Transmandibular2Product Code
- MQNExternal Mandibular Fixator And/Or Distractor2Product Code
- MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation2Product Code
- NEIProsthesis, Condyle, Mandibular, Temporary2Product Code
- NLDInstrument, Diamond, Dental, Reprocessed1Product Code
- NMWNeedle, Dental, Reprocessed1Product Code
- NYCDental Prophylaxis Kit1Product Code
- NYFGingival Retraction Kit1Product Code
- NYGLapping Tool Kit1Product Code
- NYLHandpiece, Air-Powered, Root Canal Irrigation1Product Code
- PLVDental Stereotaxic Instrument2Product Code
- PWLOral Surgery Tray1Product Code
- NVKLaser, Dental, Soft Tissue2Product Code
- OAJCatheter, Drainage, Intraoral/Extraoral1Product Code
- PEMDental Barriers And Sleeves2Product Code
- QRYDental Navigation System2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
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- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DigiGuide System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K193499
- 510(k) Type
- Traditional
- Applicant
- ProtoMED, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/4/2020
- Days to Decision
- 323 days
- Submission Type
- Summary