FDA 510(k) clearances — page 215
clearances on record, most recent first.
Clearances — page 215
21,401–21,500 of 176,479- K193566 — ZELTIQ CoolSculpting System
- K193569 — PIVO(TM)
- K192098 — EzMobile
- K193222 — Tyber Medical Anatomical Plating System
- K193045 — geko W-2
- K193548 — Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
- K181089 — SureLead Cable System
- K190306 — AMD Ritmed AssureWear VersaGown
- K190871 — Bio-TackS Orthodontic Mini Implant
- K192182 — C015
- K192211 — SoundBite Console, SoundBite Active Wire 18
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K192415 — Study Watch with Irregular Pulse Monitor
- K192495 — Black Diamond Navigation Instruments
- K192547 — MAGLUMI 2000 HCG/ß-HCG
- K192563 — Altera gas Sampling Lines
- K192583 — PicoLazer Laser System
- K192606 — SAC2 - Electrode Cream
- K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
- K192761 — Asimov-MKS Imaging System
- K192926 — RxSight Insertion Device
- K193007 — LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
- K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K193507 — Merit ONE Snare System
- K193509 — AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
- K193543 — CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
- K193547 — CustomizedBone Service
- K193570 — Dental Pain Eraser
- K193590 — CareSens S Fit BT Blood Glucose Monitoring System
- K191095 — Maxxi Snore Sensor
- K191538 — Resectr Tissue Resection Device
- K191802 — Electric Breast Pump
- K191831 — MobiliT Cup
- K192357 — INNOVO
- K192750 — AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
- K192869 — SherpaPak Lung Preservation System , SherpaPak Liver Transport System
- K192942 — ALLthread Titanium Suture Anchor
- K192956 — Auto Positioning
- K193488 — GlideScope BFlex 3.8 Single-Use Bronchoscope
- K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System
- K193611 — Viveve 2.0 System
- K181005 — ClenchGuard
- K183284 — INTRAcel RF Microneedle System
- K190028 — UNO 30
- K190981 — NEX-D2 Posterior Fixation System
- K191125 — ADAS 3D
- K191266 — VitalScan ANS
- K191275 — AllInCath 035M PTA Balloon Dilatation Catheter
- K192004 — Eko Analysis Software
- K192251 — Livento Press, Soprano 10, Soprano
- K192454 — Wattson Temporary Pacing Guidewire
- K193225 — KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
- K193493 — ADVIA Centaur Total IgE (tIgE)
- K193503 — Arthrex SwiveLock Suture Anchor
- K190316 — Icare ic200
- K191020 — G210 InviCell Plus with SignipHy pH monitoring
- K192115 — SABLE Expandable Spacer
- K192429 — Dental Pain Eraser
- K192800 — Streamline TL Spinal Fixation System
- K192920 — Oragene®Dx
- K193188 — MiiS Horus Eye Anterior Camera
- K193478 — XTRAC Momentum Excimer Laser System
- K191717 — Route 92 Medical Sheath System
- K192409 — Midwest Rhino XE and Air Motor M
- K192544 — Erchonia Emerald
- K193645 — nva, nvp, and nvt
- K183074 — TENS and EMS Stimulator, TENS Stimulator
- K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
- K191221 — Cybird LED Curing Light
- K191678 — IP Converter
- K191692 — KardioScreen
- K192307 — Nihon Kohden NKV-550 Series Ventilator System
- K192315 — Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K192966 — FlowMet
- K192995 — OsteoRemedies Hip Spacer System
- K193011 — CD Horizon Fenestrated Screw Set
- K193372 — Univers Revers Modular Glenoid System (Augemented baseplates)
- K193452 — MotoBAND CP Implant System
- K193465 — CorticaLINK Spinal Fusion Platform
- K191052 — HyaloGYN Vaginal Moisturizing Suppositories
- K191210 — Longeviti ClearFit Cranial Implant
- K192009 — LED Curing Light
- K192363 — Altapore
- K192687 — TrellOss-L MPF
- K192975 — Tyber Medical Trauma Screws
- K193433 — AMIStem-C
- K193440 — ER-REBOA PLUS Catheter
- K191489 — Genesys Spine 3DP Cervical Interbody System
- K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
- K192767 — Clear Aligner
- K192974 — Tyber Medical Trauma Screw
- K193024 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
- K193137 — EASYGRIP FLO-41 Precision MIS Delivery System
- K190651 — ERBECRYO 2 Cryosurgical Unit +4 more
- K190942 — Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
- K191870 — VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
- K192715 — CRF Radiofrequency Ablation System
- K192754 — Avenger Radial Head System
- K192774 — BioCardia 8F Morph DNA Deflectable Guide Catheter
- K191123 — Multi-unit Abutments
Data sourced from openFDA. This site is unofficial and independent of the FDA.