FDA 510(k) clearances — page 276
clearances on record, most recent first.
Clearances — page 276
27,501–27,600 of 175,699- K171874 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
- K172414 — JUD custom fit condom
- K172793 — SKR 3000
- K162340 — Stomach Tube
- K171765 — Nihon Kohden CO2 Monitor
- K171984 — Clickfine Pen Needle, Penfine Classic Pen Needle
- K172118 — U by Kotex Click Unscented Menstrual Tampons
- K172123 — NuVasive® Modulus XLIF Interbody System
- K172742 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
- K171373 — 3M Bair Hugger Model 675 Total Temperature Management System
- K171593 — InMode RF System
- K172724 — XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
- K172739 — higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
- K163526 — Bilicocoon Phototherapy System
- K170079 — Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
- K170089 — U-Motion II Acetabular System Additional sizes
- K170281 — MSA100BT Peak Flow Meter
- K170319 — Low Profile Non-Balloon Feeding Device
- K170394 — Kisses Mini
- K170470 — Digital Eye Anterior Camera
- K170672 — Tamper Evident Cap For use with ENFit Syringes
- K171397 — Sienna Ultimate Wireless Amplifier
- K171801 — IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
- K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
- K172188 — Aquilion Prime SP, TSX-303B/1, v8.4
- K172399 — MicroMatrix
- K172406 — Ingenuity TF
- K172413 — MT ONE
- K172672 — Endoscopic Applicator, 41 cm
- K172681 — Edge Air Digital Flat Panel X-ray Detector
- K172682 — Edge Digital Flat Panel X-ray Detector
- K163366 — Shanghai Sanyou CARMEN Cervical Fusion System
- K170264 — Gold AQ Blood Glucose Monitoring System
- K170344 — Tahoe Uni Knee System
- K170452 — Medacta Shoulder System
- K170548 — InSure ONE
- K171175 — Aquarius 8600 1417WC
- K171491 — R2P Destination Slender Guiding Sheath
- K171503 — Reprocessed CristaCath Diagnostic Electrophysiology Catheter
- K171689 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
- K172059 — LinkQuest Diagnostic Ultrasound System model SQ860
- K172089 — PROLENE Soft Polypropylene Mesh
- K172093 — Reprocessed Covidien Trocar
- K172099 — Shoocin Introducer Kit
- K172408 — Biomet Bone Cement R
- K172558 — iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
- K172574 — SyncVision System
- K172667 — MagVita TMS Therapy w/MagPro R20
- K172855 — Vitrea Advanced Visualization, Version 7.6
- K171182 — ri-former Predictive Thermometer
- K171991 — EMPOWR Porous Knee System
- K172092 — Reprocessed Shavers/Burs
- K172174 — Philips IntelliSite Pathology Solution
- K172289 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- K172520 — CRE RX Biliary Balloon Dilatation Catheter
- K172607 — Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
- K172671 — HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
- K172691 — Ultrasonic Generator
- K172016 — Force Fiber Fusion Suture
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
- K172285 — Ablatherm Fusion
- K172621 — HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
- K172684 — Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem
- K172884 — Arisure Closed Vial Adapter
- K163183 — Yooeehouse Breast Pump
- K170054 — iSurg
- K170375 — Nobilplast Denture Resin
- K170506 — ECG Check - Universal, ECG Check - Universal Plus
- K170873 — Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
- K171250 — BRIDALVEIL Occipital Cervical Thoracic System
- K171768 — Trident® II Acetabular System
- K171978 — Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
- K172210 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K172596 — Large Screws Range
- K163326 — SmartEP
- K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System
- K170119 — Calix Lumbar Spinal Implant System
- K170166 — CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
- K170505 — SecurePortIV Catheter Securement Adhesive
- K171309 — BR-FHUS Navigation 1.0
- K171408 — Carbon Monoxide Breath Sensor System (COBSS)
- K171440 — Berkeley VC-10 Vacuum Curettage System
- K171463 — ASPIRE Bellus II
- K171685 — Med4 Elite
- K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- K171795 — Thommen Implant System
- K172065 — SCARLET AC-T
- K172080 — Photoelectric Therapy System
- K172309 — Endoscopic Ultrasound Aspiration Needle
- K172342 — Voluson E6, Voluson E8, Voluson E10
- K172380 — U2 Diagnostic Ultrasound System
- K172397 — Sherlock 3CG Tip Positioning System Stylet
- K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K172631 — Arisure Dry Spike
- K161434 — Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
- K163442 — Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
- K163455 — SurgiCube
- K170020 — Peel-Away Introducer Set
- K170262 — Digital Thermometer
Data sourced from openFDA. This site is unofficial and independent of the FDA.