FDA 510(k) clearances — page 328
clearances on record, most recent first.
Clearances — page 328
32,701–32,800 of 176,542- K152911 — EarlySense Insight Sytem
- K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT
- K153008 — INVISION Total Ankle Revision System
- K153111 — TOUAREG CloseFit UNP 2.75mmD
- K153139 — Achieve ST Mapping Catheter, Catheter Connecting Cable
- K153506 — Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
- K153615 — NeoFuse HA Enhanced PLIF/TLIF
- K160053 — Monopolar single-use HF cable
- K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
- K150364 — ERBE ESU Model VIO dV with Accessories
- K151362 — HC Spinal System
- K152006 — Cogent Hemodynamic Monitoring System
- K152682 — Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
- K152930 — PeriFlux6000
- K153520 — Electronic Pulse Stimulator
- K153585 — Flip Button Suture Anchor
- K153620 — Enovare Ultrasound System
- K160324 — Cervical Interbody Fusion System
- K160428 — Certex Spinal Fixation System
- K160951 — Philips Efficia CMS200 Central Monitoring System
- K160952 — Alma Diode Tabletop Laser
- K161021 — HydroMARK Breast Biopsy Site Marker
- K161047 — LOGIQ P9 and LOGIQ P7
- K153277 — 6200 Ultrasound System and 6250 Ultrasound System
- K153783 — SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
- K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
- K160503 — Vented Vial Adapter Transfer Device - 13mm
- K160568 — Precision Spine Interspinous Plate System
- K160639 — Electrosurgical Generator ESG-200
- K160654 — GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- K160773 — Yarlap II
- K160936 — Certus 140 2.45GHz Ablation System
- K160986 — Xenco Medical Pedicle Screw System
- K161203 — Soehendra Stent Retriever
- K152029 — HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
- K152908 — UCP COMPACT DRUG TESTS
- K153720 — ENZA Zero-Profile Anterior Interbody Fusion
- K160050 — SERFAS 90-S Electrosurgical Probe
- K160084 — Swan Ganz Catheters
- K160118 — STROPP (Single Tunnel Repair of Plantar Plate)
- K160845 — Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link) +1 more
- K151390 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
- K151391 — BTI Dental Implant System UnicCa
- K152336 — HEX tanning booth
- K152603 — Green Laser Photocoagulator GYC-500
- K153358 — Standard Clamp
- K153673 — AirFit N20
- K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
- K160354 — MX50T(MX50TQS)
- K160357 — TRINITY
- K160609 — AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
- K160725 — EndoFLIP
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- K152084 — Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
- K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- K152299 — TBS iNsight
- K152412 — T-32; T-40; T-44; T-52; T-72; TT-50
- K152552 — Patient Monitor
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K152892 — da Vinci Xi Surgical System
- K152903 — REVIVAL(TM) Modular Revision Hip Stem
- K152973 — Dyna-Vision Telemonitoring System
- K153014 — Mobius3D
- K153064 — Blue Sky Bio Zygomatic Implant System
- K153168 — Bi-Blade Vitrectomy Cutter
- K153603 — Alphatec Navigation Instruments
- K160004 — Crosstella OTW
- K160013 — Crosperio OTW
- K160112 — Besmed PEEP Valve
- K160304 — OsteoBullet Compression Screw
- K160548 — MC-Subtalar(TM) II
- K160866 — Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
- K160869 — Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
- K150598 — Blockade Surgical Gown
- K151086 — ManoScan System
- K151502 — ARCHITECT ROMA
- K152086 — 3Shape Ortho System
- K152927 — BRILLIANT EVERGLOW
- K160128 — Endopath Electrosurgery Probe Plus II
- K152227 — Elecsys Cortisol II, Cortisol II CalSet
- K152724 — EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
- K153152 — Syzygy Stabilization System
- K153526 — Pyrenees Cervical Plate System
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K160211 — Wet Original Personal Lubricant
- K160236 — Dual Pump Pack
- K160252 — OmniPod Insulin Management System
- K152727 — ISEN-Goggles
- K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
- K153123 — Genesys Spine Apache Interbody Fusion System
- K153449 — 2008K2 Hemodialysis Machine
- K153453 — Inertia Pedicle Screw and Deformity Correxxion System
- K153602 — Materialise Glenoid Positioning System
- K160162 — Voluson P6, Voluson P8
- K160176 — Signia Stapler
- K160194 — StarFuse Interphalangeal Pin
- K160522 — White Pearl Preferred Angle Anterior Cervical Plate
- K160756 — PASS OCT Spinal System
- K160858 — CompactCath Intermittent Urinary Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.