FDA 510(k) clearances — page 333
clearances on record, most recent first.
Clearances — page 333
33,201–33,300 of 176,542- K152206 — SurgiPure XD Reconstructive Tissue Matrix
- K152262 — Ventix Knotless Anchors
- K152766 — CharmFlex
- K152815 — Mailuokang Self-adhesive Electrode
- K152882 — Propeller System
- K153270 — TruGuard Custom Tongue and Jaw Positioner
- K153326 — Erisma-LP Spinal Fixation System
- K160085 — Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
- K150731 — Medline Epidural Catheter
- K150876 — Bead Block
- K152614 — Xpert Carba-R
- K152824 — MEDT PEN NEEDLE
- K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
- K153244 — Cios Fusion
- K153400 — ProLift Expandable System
- K153430 — Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
- K160025 — iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
- K160041 — Cobbra RF Tissue Dissector
- K160418 — PERIMETER Interbody Fusion Device
- K150144 — VisuCon-F Low Fibrinogen Control Plasma
- DEN140017 — SENSIMED TRIGGERFISH
- K151136 — HARMONIC HOOK
- K151590 — Straumann RN Gold Abutment for Bridge
- K151597 — Family of Steam Sterilizers B 28 series
- K151789 — LOCATOR F-Tx Attachment System
- K151847 — SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
- K152238 — Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
- K152249 — ASAHI Corsair Armet
- K152402 — IRTS Thermal Imaging Probe (TIP); IRTS Patient Monitoring Unit (PMU); IRTS Patient Interface Unit (PIU)
- K152421 — IS4000 Stapler 30 Instrument and Stapler 30 Reloads
- K152482 — Propeller Sensor Model 2014-R
- K152547 — DNAP Electrode
- K152861 — Aquasil Ultra + Smart Wetting Impression Material
- K152897 — Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
- K152957 — MultiCross Catheter
- K153212 — Sheathes Ultrasound Probe Covers
- K153346 — syngo Application Software VD11
- K153513 — Insufflator 50L FM134
- K160237 — Cefaly
- K160257 — PROTEK Duo 31 Fr. Veno-Venous Cannula Set
- K160272 — Endophys Pressure Sensing Sheath Kit
- K160301 — Platinum dRF Imaging System
- K160426 — syngo.via MI Workflows
- K151123 — Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
- K151745 — FULL CARE Disposable PVC Nelaton Catheter
- K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
- K152602 — Olea Sphere V3.0
- K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
- K153253 — GC Reline II
- K153299 — Tenex Health TX System
- K153448 — Passport Series Patient Monitors (Including Passport 8, Passport 12)
- K153746 — Dunamis Force DFX Tensile Tape
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K160347 — Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
- K151024 — Finger Type Pulse Oximeter
- K151700 — BEAUTIFIL II Gingiva
- K151708 — RECON system - Compression Screws
- K152050 — Pencylcap
- K152280 — BioPhotas Celluma3
- K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit
- K153044 — Sentimag System, Sentimark Magnetic Marker Systerm
- K153245 — Baha 5 Super Power Sound Processor
- K153438 — PERIMETER C (Titanium) Spinal System
- K153527 — PicoWay Laser System
- K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
- K160241 — Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
- K143482 — xevonta dialyzer
- K150789 — SPINAUT-E, SPINAUT-I
- K151905 — 3400E series; E5400 series; E6400 series; Sundazzler series
- K152681 — iFuse Implant System(R)
- K152719 — Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves
- K152748 — Braun Thermoscan PRO 6000 Ear Thermometer
- K153237 — OrthAlign Plus System
- K153460 — Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
- K160185 — Wrist 3
- K160230 — VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
- K150468 — Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
- K150597 — ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
- K152932 — BlastGen
- K153199 — Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
- K160317 — syngo.via MI Workflows
- K151307 — ICONACY(TM) I-Hip (TM)
- K151476 — Beactive Brace
- K151482 — BCR-30-min BI and RBIP-ST30 Readout Accessory
- K151743 — THUNDERBEAT Open Fine Jaw
- K152082 — Vesocclude Polymer Ligating Clip
- K152416 — Indego
- K152626 — H3+ Holter Recorder
- K152765 — VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
- K152855 — VIVIX-S 1012N
- K152894 — VIVIX-S 1717N
- K153191 — Calcium Bridge
- K153275 — Aingeal Activity System
- K153295 — TandemLung Oxygenator
- K153424 — E-CUBE i7
- K153575 — Tyber Medical Trauma Screw
- K160003 — Sniper (R) Spine System
- K160171 — Illuminated Mediastinal Access Port
- K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
- K160182 — LOGIQ S7 Expert
Data sourced from openFDA. This site is unofficial and independent of the FDA.