FDA 510(k) clearances — page 284
clearances on record, most recent first.
Clearances — page 284
28,301–28,400 of 176,542- K172728 — Applanation tonometer AT-1
- K172806 — Bencox Mirabo Cup System
- K172817 — 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
- K162042 — OptiScanner 5000 Glucose Monitoring System
- K170819 — AcQMap 3D Imaging and Mapping Catheter
- K170948 — AcQMap High Resolution Imaging and Mapping System
- K171879 — HylaGuard Moisturizing Cream
- K171974 — Solana RSV+hMPV Assay
- K172186 — BioWick X Implant with Driver
- K172487 — Coaxial Dilator Set (Micro-Introducer)
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K162362 — PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
- K163277 — SuperNO2VA Device
- K163653 — NOVOS-NAIL Limb Lengthening System (LLS)
- K163696 — SleepImage System
- K170151 — Electronic Blood Pressure Monitor
- K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
- K170233 — Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
- K170241 — GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
- K171015 — Citryte
- K171120 — Senhance Surgical Robotic System
- K171286 — PAL Multi-Use Cannulas and PAL Manual Wand
- K171548 — Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
- K171702 — Exciplex308nm
- K171916 — Single Use Hot Biopsy Forceps FD-231
- K172023 — CELFIRM
- K172181 — micro IPL
- K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
- K172435 — Galaxy R Digital Radiography Upgrade
- K172454 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
- K172498 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
- K172772 — Freemie Independence, Freemie Liberty
- K172784 — DX-D Imaging Package
- K170085 — SONON Ultrasound Imaging System, Model: 300L
- K170146 — Galaxy UNYCO System
- K170147 — Lucica Glycated Albumin-L
- K170154 — Creavo Vitalscan Magnetocardiograph
- K170840 — MAGNETOM Terra
- K171169 — Aquarius 8600 1417TG and Aquarius 8600 1717TG
- K171279 — Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
- K171497 — Mikron Spinal Fixation System
- K171782 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
- K171796 — Vial Adapter 15mm
- 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 +2 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.