FDA 510(k) clearances — page 196
clearances on record, most recent first.
Clearances — page 196
19,501–19,600 of 175,699- K192310 — Flap Fixator, Burr Hole Cover
- K193021 — Vantage Orian 1.5T, MRT-1550, V6.0
- K193226 — AltiVate Anatomic Canal-Sparing (CS) Shoulder
- K200268 — Halo Single-Loop Snare Kit
- K200459 — pREBOA-PRO Catheter
- K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
- K200514 — Cardioblate Gemini-s Surgical Ablation Device
- K200602 — Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
- K200721 — Agilis HisPro Steerable Catheter With Electrodes
- K200907 — Thales 3D Mr Scanner
- K200929 — Hair Growth System
- K200974 — QLAB Advanced Quantification Software
- K201175 — StealthStation Cranial Software v1.3.0
- K192779 — Bunny Wax Personal Lubricant
- K193307 — HIP7
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
- K200089 — F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
- K200322 — Altus Spine Pedicle Screw System
- K200528 — Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
- K200532 — StarPore
- K200684 — gastroduodenal FTRD Set
- K200889 — iMac 27 & PL 4.0
- K200911 — MIRA Adapter
- K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
- K201202 — MI View&GO
- K191620 — Vitls Platform
- K192601 — uWS-MR
- K192864 — UNI*FUSE Infusion System with Cooper Wire
- K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
- K193319 — XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
- K193361 — ProCell Surgical Sponge-Blood Recovery Unit
- K193577 — SleepRight ProRx Custom Dental Guard
- K200134 — Jimushi Sterile Urethral Catheter for single use
- K200536 — 3MTM AttestTM Rapid 5 Steam-Plus Test Pack
- K200538 — Skeletal Dynamics Forearm Plating System
- K200540 — BRAINSTREAM Disposable Deep Cup EEG Electrodes
- K200897 — Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
- K190982 — Automatic Digital Blood Pressure Monitor
- K191334 — Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
- K192262 — Dental Zirconia Blocks
- K192420 — Crownjun Nylon Suture
- K193495 — XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
- K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
- K200002 — Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
- K200235 — KONG-TL VBR System, KONG-C VBR System
- K200509 — ADVIA Centaur Vitamin D Total (VitD)
- K200511 — ROSA ONE Brain application
- K200629 — Aspire Mechanical Aspirator G
- K200920 — Idys ALIF ZP 3DTi
- K201172 — CFP-3131, CFP-2222
- K201178 — iLab Polaris Multi-Modality Guidance System
- K201189 — Stealthstation S8 Spine Software v1.3.0
- K192692 — Brainomix 360 e-CTA
- K192981 — Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
- K193539 — REVOLVE ENVI 600 Advanced Adipose System
- K193665 — Frozen N
- K200116 — PicoSecond Nd: YAG Laser System
- K200885 — Meridian Anterior Plate System, Regatta Lateral Plate System
- K200979 — DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
- K201131 — firefly T-2
- K192418 — Phacoemulsification Needle (Tip) and Irrigation Sleeve
- K192449 — Joline Kyphoplasty System Allevo
- K192652 — TRV
- K192914 — Stimuplex Onvision System
- K193233 — Restoration® Modular Hip System
- K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
- K200253 — Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
- K200525 — Medical Diode Laser Hair Removal System
- K200984 — Guardian Needle Electrode
- K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- K181691 — High-speed air turbine handpiece / Low-speed air turbine handpiece
- K192392 — DiaPlus
- K193441 — Aqua Naina Sterile Saline Solution
- K193460 — The iNAP One Sleep Therapy System
- K200032 — ReWalk P6.0
- K200305 — NPseal
- K200944 — UNIEXPERT 2 PLUS
- K200988 — Maximus System
- K201111 — GentleMax Pro Plus
- K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
- K201130 — ACUSON Juniper Diagnostic Ultrasound System
- DEN190037 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
- K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
- K191847 — Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps
- K192488 — CO2 Sidestream Module
- K192560 — Surgical Gown
- K193423 — VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
- K200126 — VERIFY Assert Self-Contained Biological Indicator
- K200246 — JPS JuniOrtho Plating System
- K200410 — Reconnaissance PV .018 OTW Digital IVUS Catheter
- K200419 — Kalera Vacuum Aspiration Catheter (K-VAC)
- K200457 — Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
- K200936 — Invictus CT Spinal Fixation System
- K191512 — LotusCatheter (Lotus No Balloon Catheter)
- K192265 — gi-4000 Electrosurgical Generator
- K192342 — Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
- K192446 — CO2 Mainstream Module
- K192879 — Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
- K193391 — BeneVision Central Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.