FDA 510(k) clearances — page 292
clearances on record, most recent first.
Clearances — page 292
29,101–29,200 of 175,699- K160990 — Nova Max Uric Acid Monitoring System
- K162046 — MINNE TIES MMF Suture System
- K163021 — HAAG-STREIT FUNDUS MODULE 300
- K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
- K163617 — REMbrandt
- K163698 — OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
- K170445 — LOGIQ S8
- K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution
- K170580 — Carestream Vue PACS
- K170788 — CyberKnife Treatment Delivery System
- K162068 — ARROW Anatomical Porous glenoid
- K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- K162968 — VORTRAN GO2VENT
- K163125 — geko T-2 and geko Plus R-2 Neuromuscular Stimulators
- K163192 — Comfort EC710
- K163271 — i-Stat Alinity System with i-Stat Glucose test
- K163386 — Keos Lumbar IBFD
- K152192 — LED Curing Light
- K160549 — MEDICAL DIODE LASER SYSTEMS
- K160694 — Disposable Endotracheal tube, sterile, AccuCuff
- K162838 — Philips iCT CT System
- K162877 — VOCSN Unified Respiratory System
- K163144 — gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
- K163265 — Kepler II
- K163361 — ANTHEM Fracture System
- K163372 — RX Takeru Balloon Dilatation Catheter
- K170059 — Spectranetics Turbo-Elite Laser Atherectomy Catheters
- K170598 — ZeroWire Mobile
- K170724 — NeuroBlate System
- K170813 — ORTHOPANTOMOGRAPH OP 3D
- DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
- K153763 — Howell Biliary Aspiration Needle
- K160323 — FlowKeepers
- K161599 — UNO Negative Pressure Wound Therapy System
- K161829 — Huvitz Imaging System
- K162203 — POGO Automatic Blood Glucose Monitoring System
- K162287 — Synapse 3D Perfusion Analysis
- K162488 — Optiflux dialyzer
- K162617 — NobleStitch EL
- K162925 — AcQGuide Steerable Sheath
- K162927 — PRECICE UNYTE CoCr System
- K163101 — CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
- K163220 — Atellica CH Phencyclidine (Pcp)
- K163233 — MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
- K163246 — Leva Anterior Expandable Spacer System
- K163256 — Dual Mode Infrared Thermometer
- K163469 — ViziShot 2 FLEX
- K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
- K170171 — IOLMaster 700
- K170385 — CORE M2 Vascular System
- K170700 — Inqwire Diagnostic Guide Wire
- K161332 — NILE Proximal Fixation Spinal System
- K161341 — LIFESYS PACS
- K161712 — Arm automatic blood pressure monitor
- K161919 — UltraScan 650
- K161982 — C-Reactive Protein Kit for use on SPAPLUS
- K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K163076 — Segment CMR
- K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
- K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
- K163435 — Entellus Medical Reinforced Anesthesia Needle
- K163509 — XprESS ENT Dilation System
- K163711 — IQon Spectral CT
- K170377 — TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
- K170456 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K170668 — HeartSpan Steerable Sheath Introducer
- K170677 — Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
- K170719 — Anzai Respiratory Gating System
- K170837 — Nio Color 3MP (MDNC-3421)
- K162206 — Zavation IBF
- K162544 — OsteoMed PINNACLE Driver
- K162782 — iHelmet Hair Growth System
- K163221 — Mazor X
- K163303 — OsteoMed ExtremiFix Mid and Large Screw System
- K163458 — Zenysis Short-Term Dialysis Catheter
- K163459 — Nihon Kohden Vital Sign Telemeter
- K163613 — Bluephase Style 20i
- K170040 — BePOD Cannulated Arthrodesis Screws
- K170315 — Acuson SC2000 Diagnostic Ultrasound System
- K170347 — CD HORIZON Fenestrated Screw Set
- K170411 — ER-REBOA Catheter
- K170560 — SAGE Vitrification Kit and SAGE Vitrification Warming Kit
- K170678 — Beta-CrossLaps CalCheck 5
- K170731 — System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
- K170781 — MX50N(MX50YQS)
- K161353 — ESTELITE BULK FILL Flow
- K162241 — TITAN 3-D Wedge System
- K163426 — ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
- K170075 — AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
- K161257 — MultiPulse HoPLUS
- K161530 — Bluetooth blood pressure monitor
- K161635 — AMIStem-H Proximal Coating
- K162167 — Caphosol Artifical Saliva Tablets
- K162186 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
- K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software
- K162413 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K162530 — Multichem IA Plus
- K162559 — Move Forward 3D Motion Simulation Service
- K162626 — THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
- K162627 — EnsoSleep
Data sourced from openFDA. This site is unofficial and independent of the FDA.