FDA 510(k) clearances — page 325
clearances on record, most recent first.
Clearances — page 325
32,401–32,500 of 175,699- 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
- K160392 — Novilase Laser Therapy System, Model LTS-2
- K151406 — Cogent Lateral Interbody System
- K151435 — MRCAT
- K151508 — IRENE Locking Compression Plate System
- K151737 — MedicVOD System
- K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic)
- K152141 — High Pressure Tanning Lamps
- K152332 — Perfectio LED infrared device
- K152438 — ETView VivaSight-SL (TVT) system
- K152593 — LATEX EXAMINATION GLOVE POWDER FREE
- K152691 — EDS Universal Cement
- K152715 — HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K152736 — SKIN CARE
- K152989 — Mammotome revolve Dual Vacuum Assist Biopsy System
- K153091 — IMPLANT 3D
- K153135 — VITAL SIGNS MONITOR
- K153443 — ASAHI Astato XS 40
- K153488 — Occlusion Perfusion Catheter
- K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200
- K153617 — OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
- K153677 — The Cellfina System
- K153759 — SIGN Compression Screw System
- K160063 — McLaren Proton Therapy System
- K160164 — BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- K160184 — Voluson S6, Voluson S8, Voluson S10
- K160328 — DIVA ZSP2105CMI with QUBYX PerfectLum bundle
- K150304 — Oxyless Blood Tubing Set
- K151337 — Strialite
- K152085 — Liquid CO2-2 (LCO2-2)
- K152088 — IV-eye
- K152310 — HeartLight Deflectable Sheath
- K152539 — SpineView X-Pac Expandable Lumbar Cage System
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
- K153588 — EndoChoice Water Bottle Cap System
- K160161 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K142969 — ANI Monitor
- K151092 — Arthrex Short Suture Anchors
- K151717 — twion
- K152034 — FS-PACS
- K152160 — Navik 3D
- K152557 — Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
- K152831 — Spot Skan
- K153323 — Palisade Pedicular Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.