FDA 510(k) clearances — page 219
clearances on record, most recent first.
Clearances — page 219
21,801–21,900 of 175,699- K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform
- K192071 — iNSitu Total Hip System
- K192074 — Signature ONE System
- K182219 — SGS Dental Implants System
- K182382 — Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
- K182811 — gel-e Flex+
- K183489 — D2P
- K183605 — Spine & Trauma Navigation
- K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
- K190236 — O2Vent Optima
- K190613 — BD MAX Check-Points CPO
- K190744 — ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
- K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
- K191281 — Omni Hysteroscope, Omni Lok cervical seal
- K191319 — Dunamis Fixation Button System
- K191439 — OverStitch 2-0 Polypropylene Suture
- K191475 — Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
- K191939 — Yushan X-Ray Flat Panel Detector
- K192035 — EvaQMax Smoke Evacuation System
- K192036 — ClotTriever Thrombectomy System
- K192042 — Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
- K192054 — Endoskeleton TAS Plate
- K192076 — Binary® Anterior Cervical Plate System
- K192107 — Clarius Ultrasound Scanner
- K192159 — Voluson E6, Voluson E8, Voluson E10
- K182142 — FEMME Applicator Tampon
- K182401 — B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
- K183485 — CryoVizion System
- K190269 — PureLift
- K190437 — Delta 3300
- K190704 — Signature Ceramic Femoral Head
- K190904 — Conformis BeneFIT Hip System
- K191399 — BIOLOX CONTOURA Ceramic Femoral Head
- K191414 — EXETER Centralizer, EXETER 2.5mm Plug
- K191424 — Interphalangeal Joint Fusion Device Range
- K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
- K191569 — Implantcast ic-Bipolar Head System
- K191778 — Omnia Medical VBR
- K191780 — AP50/30 Insufflator with Insuflow Port
- K191810 — Curiteva Pedicle Screw System
- K191077 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
- K191107 — Plexus
- K191039 — Navigated T2 STRATOSPHERE Inserters and Navigated Templates
- K191382 — IPS e.max CAD Abutment Solutions- extra systems
- K191427 — Halley resin system
- K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K183122 — 810nm Diode Laser System
- K182950 — Acare Suction Unit
- K183315 — CustMBite Dental Guard
- K183544 — Efficient Care 3D Planning
- K183567 — Vyntus/SentrySuite Product Line
- K183607 — FUJIFILM Bronchoscope
- K183684 — Libertas Taper Uncemented Femoral Stem
- K190127 — Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
- K190459 — Hemoflow F3 and F4 Dialyzers
- K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
- K190813 — CrossBay Cervical Dilator Catheter System
- K191063 — 1-Step Culture Medium
- K191119 — EkoSonic Endovascular Device
- K191130 — Customized Contour Implant
- K191177 — LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
- K191180 — Electronic Blood Pressure Monitor
- K191412 — VariAx 2 System, VariAx 2 Mini Fragment System
- K191809 — MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
- K191981 — REMEDY Acetabular Cup
- K191990 — OSW Aligner System
- K192047 — Rampart One Lumbar Interbody Fusion System
- K181888 — Osstell Beacon
- K190126 — Bendit2.7 Steerable Microcatheter
- K190402 — Triathlon Total Knee System-Additional Components
- K190792 — BB-613WP
- K191242 — HEALIX ADVANCE SP BIOCOMPOSITE Anchor
- K191393 — INFINITY Total Ankle System, INBONE Total Ankle System
- K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- K192021 — NCB Polyaxial Locking Plate System
- K183390 — QNext and DG-PT
- K190026 — Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
- K190044 — VSP Orthopedics System
- K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
- K191623 — ScanX Touch/ScanX Duo Touch
- K191948 — GlideScope BFlex 5.8 Single-Use Bronchoscope
- K182086 — ARCO FP
- K191561 — Exactech Equinoxe Humeral Augmented Trays
- K191936 — iNSitu Total Hip System
- K183356 — Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
- K190207 — Blood Pressure Monitor
- K191339 — Zavation eZspand Interbody System
- K191342 — CrossRoads Screw System
- K191985 — Optilite IgA Kit
- K183108 — Combined Aerobika OPEP and VersaPAP device
- K183536 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- K190722 — TriMAX Implant System
- K190735 — EQ Balance
- K190853 — Vyntus BODY
- K190988 — GIM-STIM OTC TENS/EMS System
- K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED
- K191349 — 980nm Diode Laser Therapy Device
- K191504 — PowerDR
- K191609 — Tria Soft Ureteral Stent
Data sourced from openFDA. This site is unofficial and independent of the FDA.