FDA 510(k) clearances — page 223
clearances on record, most recent first.
Clearances — page 223
22,201–22,300 of 175,699- K191579 — Voyant System
- K191594 — Nuvis Battery Arthroscope
- K182471 — Scooter
- K182829 — Scepter Mini Occlusion Balloon Catheter
- K182875 — DeepCT
- K183041 — Full Digital Colour Doppler Ultrasonic Diagnostic System
- K183079 — Conometric Abutments
- K183243 — Velofix TLIF Cage
- K183322 — physIQ Heart Rhythm and Respiratory Module
- K190011 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
- K190107 — VeriSplint
- K190137 — Identify
- K190528 — MariGen Wound Extra
- K190620 — SpeediCath Flex Coude Pro
- K190801 — PressOn Electrode Headset
- K190818 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K191045 — Salvo Spine System
- K191408 — Nexxt Matrixx System
- K191541 — Vave Personal Ultrasound System
- K191557 — CentriMag Acute Circulatory Support System
- K191589 — Calprest, EasyCal
- K191592 — CalprestNG, EasyCal
- K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
- K181957 — Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
- K182163 — Shear Stress Therapeutics SST 3000
- K183623 — LifeSPARC Pump, LifeSPARC Controller
- K190969 — ENDOSCOPE REPROCESSOR OER-Elite
- K191162 — EpiLaze Multi-wavelength Laser
- K191252 — Gem FlowCoupler System
- K180365 — PRAMA White Implant Systems
- K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®)
- K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
- K182615 — Surgikor Dental Implant System
- K183050 — GLISSANT Intimate Lubricant
- K183153 — Microwave Ablation System
- K190064 — nView system 1
- K190277 — ProVate Vaginal Support
- K190286 — Materialise Glenoid Positioning System
- K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- K191384 — RayCare 2.3
- K191580 — BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
- K182414 — Aesculap® SterilContainer(TM) S2 System
- K182901 — Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
- K182904 — syngo.MR Applications
- K190174 — Miethke Shunt System GAV 2.0 and SA 2.0 Valves
- K190254 — Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
- K190324 — OrthoPediatrics Cannulated Screw System
- K190456 — BTL 799-2L
- K190498 — Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
- K190548 — BIOMONITOR III, Remote Assistant III
- K190594 — AngioVac C20, AngioVac C180
- K190645 — Arthrex NanoScope System
- K190924 — Revitive Medic Plus, Revitive Advanced 2
- K191238 — Zimmer Guide Wire Devices
- K191367 — Harrier-SA Lumbar Interbody System
- K183149 — Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
- K190950 — Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
- K180968 — AlphaDent Implants Dental Implants System
- K182580 — Novidia Flowable Composite
- K182780 — XP Composite
- K183058 — Arm-type Electronic Blood Pressure Monitor
- K190272 — Bluephase PowerCure
- K190442 — Koios DS for Breast
- K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
- K190724 — MD-Temp Plus
- K190915 — OsteoFab Suture Anchors
- K190959 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
- K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
- K191169 — NuVasive® Camber Laminoplasty System
- K191204 — Infinity Fixation System
- K191451 — CMDR 2CW (Multiple models)
- K191468 — syngo.CT Dual Energy
- K191495 — Biopsy Positioner
- K182876 — Uro-N Cystoscope
- K183138 — Certain BellaTek Express and BellaTek Flex Abutments
- K190351 — Site Seal SV
- K190617 — Wrap accessory electrodes
- K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
- K190687 — Twilite Appliance
- K191008 — iLab Polaris Multi-Modality Guidance System
- K191137 — 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
- K191460 — PWD Platform Wound Dressing 3 x 5 Oblong
- K182847 — Hudson RCI Voldyne Volumetric Exerciser
- K183062 — ASAHI Silverway
- K183173 — LIGHTMED Ultrasound System
- K190166 — TriMed Nitinol Staple System
- K190524 — MRopen 0.5 T
- K190550 — IKON 40 Manual Wheelchair
- K190905 — BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL)
- K190980 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
- K181672 — SureTouch Mobile Pressure Mapping System
- K183021 — ClearEndoclip
- K183064 — TxTi IBF System
- K183389 — Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
- K190101 — UltraFlex IAB
- K190251 — RecoveryRx
- K190341 — iC-GN iC-Cassette for use on the iC-System
- K190475 — Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
- K190516 — MicroLink All-Suture Button Fixation System (Radiolucent)
- K190582 — MicroLink All-Suture Button Fixation System (Radiopaque)
Data sourced from openFDA. This site is unofficial and independent of the FDA.