FDA 510(k) clearances — page 363
clearances on record, most recent first.
Clearances — page 363
36,201–36,300 of 176,542- K142465 — Aquilion ONE Vision, v7.0
- K143114 — Sense4Baby System Model B+ (MSA)
- K143318 — DR Systems Zero Download 3D Viewer (Z3D)
- K143414 — Hill-Rom Wireless Connectivity Module
- K143519 — The MeDioStar NeXT Family
- K143753 — Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
- K150307 — RESTORIS Multicompartmental Knee System
- K141717 — PACSEAL PIT & FISSURE SEALANT
- K141767 — ID MILLENNIUM, ID MOMENTS SILICONE
- K141981 — ASAHI FUBUKI 043 / ASAHI FUBUKI
- K142782 — KIMGUARD ONE-STEP Sterilization Wrap
- K142808 — CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
- K150158 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K150275 — Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
- DEN130046 — REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
- K141536 — VIEWING CLIENT MOBILE
- K141790 — AQANIFE
- K141793 — PULMONE MINIBOXPFT 2.0
- K142341 — X-RAY TV SYSTEM SONIALVISION G4
- K143109 — XP300
- K143389 — 3.0T GEM RT Open Array
- K143419 — Patient Examination Gloves
- K143537 — Sirius Starmobile tiara
- K150322 — InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
- K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE
- K141467 — SURGICAL GOWN
- K141518 — Nellcor Bedside Respiratory Patient Monitoring System
- K141655 — QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
- K141740 — INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
- K141975 — WATERLASE IPLUS S
- K142438 — Nerve Monitoring Cable System
- K142464 — Entriport
- K142923 — TraumaCad Mobile Release 1.0
- K142960 — Propeller System 2014-R
- K143094 — QuantaFlo
- K143100 — NP Cement HV Genta; NP Cement LV Genta; NP Cement HV System Genta; NP Cement LV System Genta
- K143134 — NP Cement HV; NP Cement LV; NP Cement HV System; NP Cement LV System
- K143160 — FOXTROT NC PTCA Balloon Catheter
- K143388 — Affix IIS Spinous Process Plate System
- K143526 — The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
- K143564 — Visual-ICE Cryoablation System, Software Revision 1.3.1
- K143616 — AccuLIF TL and PL Cage
- K143646 — MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
- K150258 — Vitrea, Version 7.0 Medical Image Processing Software
- K150285 — Leva(TM) Spacer System
- K130238 — NIHON KOHDEN AE-918P NEURO UNIT
- K133789 — DOLPHIN NEUROSTIM OTC
- K142732 — T3 Software
- K142916 — SVED Wound Treatment System
- K142953 — OCT-Camera
- K142983 — AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
- K142990 — Insta-Gard Surgical and Procedure Face Mask
- K143087 — Hospira Blood Set
- K143331 — Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
- K143485 — iGuide 2.1
- K143492 — OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
- K143552 — Simpliciti Shoulder System
- K143645 — EsophyX® Z Fastener Delivery Device
- K143673 — CMOS Video Nasopharyngoscope System
- K143725 — Consensus Knee System Modular Tibial Baseplate
- K150004 — SALVATION External Fixation System
- K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
- K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
- K150249 — ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
- K150309 — Extremity Medical Calcaneal Osteotomy Device
- K150360 — TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
- K141825 — IDEAL Locking Plate System
- K141867 — ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
- K143301 — NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
- K142338 — Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
- K142734 — TRILLIUM Oval MR System
- K143453 — Mpact Double Mobility System
- K150085 — GE EchoPAC
- K140990 — EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
- K141123 — ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
- K141183 — EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
- K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
- K141559 — V-GUIDE FOR VENTRICULOSTOMIES
- K141922 — IRIS INTELLIGENT RETINAL IMAGING SYSTEM
- K142119 — PROCOTYL L-O ACETABULAR SYSTEM
- K142172 — LIGHTMED TRUSCAN 577
- K142731 — HEARTWAY Electrically Powered Wheelchairs
- K143303 — Single Use Biliary Balloon Dilator
- K143314 — Progressive Orthopaedic Total Hip System
- K143439 — KATANA Zirconia
- K143576 — Exactech Ambassador
- K150201 — Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
- K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY
- K142498 — MAGNIFY and MAGNIFY-S Spacers
- K142576 — Spinal System
- K142623 — PANAVIA SA Cement Plus Handmix
- K142985 — UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
- K143228 — Ancora LLC Interbody Fusion Device
- K143323 — OS2-V Varisation Staple
- K143373 — IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
- K143415 — Air Bubble Based Infuser (ABBI)
- K143652 — Vector PTA Balloon Dilatation Catheter
- K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
- K150174 — EMMA
- K150190 — IntraTemp Solution Warmer
Data sourced from openFDA. This site is unofficial and independent of the FDA.