FDA 510(k) clearances — page 69

176,479 clearances on record, most recent first.

Clearances — page 69

6,801–6,900 of 176,479

K241860 — Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited·Product code GEX·2024-09-25
K242075 — Indigo® Aspiration System Lightning Bolt Aspiration TubingPenumbra, Inc.·Product code QEW·2024-09-25
K242204 — Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)Dongguan Quanding Medical Supplies Co., Ltd.·Product code GEI·2024-09-25
K242273 — Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation·Product code MQV·2024-09-25
K242299 — NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC·Product code MQV·2024-09-25
K233807 — LumiVy Lumbar IBF SystemVy Spine, LLC·Product code MAX·2024-09-24
K234134 — AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)·Product code BZD·2024-09-24
K240236 — Happy Ring Health Monitoring SystemHappy Health, Inc.·Product code MWI·2024-09-24
K240776 — Celsio Flexible Cryocatheter SystemEndocision Technologies, Inc.·Product code GEH·2024-09-24
K241874 — Aspiration Catheter (2189)Hobbs Medical, Inc.·Product code OCX·2024-09-24
K242070 — Ion Endoluminal System (IF 1000)Intuitive Surgical, Inc.·Product code EOQ·2024-09-24
K242292 — uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd.·Product code QAS·2024-09-24
K240013 — EchoGo Heart Failure (2.0)Ultromics Limited·Product code QUO·2024-09-23
K240243 — EConsole2DRTECH Corporation·Product code LLZ·2024-09-23
K241570 — Unity Total Knee SystemCorin U.S.A. Limited·Product code JWH·2024-09-23
K241834 — IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.·Product code OHT·2024-09-23
K232670 — HiCardi+ H100MEZOO Co., Ltd.·Product code DSH·2024-09-20
K233153 — Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.·Product code HBC·2024-09-20
K234108 — ERI Portable X-ray System (3 models)Energy Resources International Co., Ltd.·Product code IZL·2024-09-20
K234129 — Ecomed Disposable Administration SetsEcomed Solutions, LLC·Product code FPA·2024-09-20
K240036 — PIUR tUS InfinityPiur Imaging GmbH·Product code QIH·2024-09-20
K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.·Product code JDS·2024-09-20
K240420 — NeuroField Analysis SuiteNeurofield, Inc.·Product code OLU·2024-09-20
K240604 — MTONE EVO (MTONE EVO)M&T S.R.L.·Product code GEX·2024-09-20
K240722 — Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC·Product code FRO·2024-09-20
K241332 — aprevo® anterior and lateral lumbar interbody fusion device +2 moreCarlsmed, Inc.·Product code MAX·2024-09-20
K241821 — Luer Lock Syringe with Safety Needle +2 moreSol-Millennium Medical, Inc.·Product code FMF·2024-09-20
K241825 — Microwave Ablation AntennasCanyon Medical, Inc.·Product code NEY·2024-09-20
K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.·Product code EFB·2024-09-20
K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.·Product code MAX·2024-09-20
K242223 — SuperSonic HepaVuSupersonic Imagine·Product code IYN·2024-09-20
K242504 — Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.·Product code NRY·2024-09-20
K242650 — zLOCK Lumbar Facet Fixation SystemZygofix , Ltd.·Product code MRW·2024-09-20
K234096 — MonoStereoMedicaltek Co., Ltd.·Product code EOB·2024-09-19
K240183 — Star E900 Handpiece SeriesDentalez, Inc., Stardental Division·Product code EGS·2024-09-19
K240901 — StethophoneSparrow Acoustics, Inc.·Product code DQD·2024-09-19
K241465 — Midas Flowmeter; eAVSParker Hannifin Corporation·Product code BZR·2024-09-19
K241709 — Pectus Blu Support Bar SystemBiomet Microfixation·Product code HRS·2024-09-19
K242162 — Coconut HybridGood Clean Love, Inc.·Product code NUC·2024-09-19
K242167 — Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.·Product code MUI·2024-09-19
K242478 — GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.·Product code KPR·2024-09-19
K242509 — HAnano InterFuse(R) Modular InterbodyNext Orthosurgical·Product code MAX·2024-09-19
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A.·Product code FRC·2024-09-18
K231893 — LOWTEM Crystal 120Lowtem Co., Ltd.·Product code MLR·2024-09-18
K233064 — Copra SupremeWhitepeaks Dental Solutions GmbH·Product code EIH·2024-09-18
K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.·Product code NHA·2024-09-18
K234153 — EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)Edgelife Technologies, LLC·Product code IYN·2024-09-18
K241123 — Perpak Sterilization Tyvek PouchKm Corp.·Product code FRG·2024-09-18
K241424 — InnoCare Specialty Foley CatheterInnocare Urologics, LLC·Product code EZL·2024-09-18
K241769 — Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC·Product code KTT·2024-09-18
K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.·Product code NDN·2024-09-18
K241784 — Arrow® Nitinol WireTeleflex Medical·Product code DQX·2024-09-18
K233721 — KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.·Product code DZL·2024-09-17
K234132 — Medline Reusable Sterilization WrappersMedline Industries, LP·Product code FRG·2024-09-17
K240250 — 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.·Product code MAX·2024-09-17
K240274 — PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation·Product code PKL·2024-09-17
K240293 — STSTechbopulm, Ltd.·Product code BZC·2024-09-17
K240373 — Air compression Leg Massager (MM0520, MM0521, MM0522)Zhangzhou Easepal Medical Science and Technology Co., Ltd.·Product code IRP·2024-09-17
K240660 — Signum composite flow +6 moreKulzer, LLC·Product code EBF·2024-09-17
K240689 — Robin's EggTelebrands Corporation·Product code OAP·2024-09-17
K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd.·Product code DYB·2024-09-17
K241942 — TriMed Bridge PlatesTriMed, Inc.·Product code HRS·2024-09-17
K242186 — Neo Sculptor (OF-NEO001)Ofan Intelligent Technology (Guangzhou) Co. , Ltd.·Product code NGX·2024-09-17
K232938 — Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.·Product code HBC·2024-09-16
K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapO&M Halyard, Inc.·Product code FRG·2024-09-16
K234089 — DNA ApplianceVivos Therapeutics·Product code LRK·2024-09-16
K240638 — Power Wheelchair (YH-E7007)Ningbo Youhuan Automation Technology Co., Ltd.·Product code ITI·2024-09-16
K241201 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2024-09-16
K241335 — Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated·Product code SBA·2024-09-16
K241379 — Powered Wheelchair (NXN20-205, NXN20-205M)Zhejiang Nysin Medical Co., Ltd.·Product code ITI·2024-09-16
K241762 — OneMarkView Point Medical·Product code NEU·2024-09-16
K241771 — Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.·Product code GEX·2024-09-16
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL·Product code OLO·2024-09-16
K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service and Savings, Inc.·Product code NLH·2024-09-14
K233399 — Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.·Product code FRO·2024-09-13
K234063 — T2Candida 1.1 PanelT2biosystems, Inc.·Product code PII·2024-09-13
K240087 — RT Carbon ECG LeadsIvy Biomedical Systems, Inc.·Product code DSA·2024-09-13
K240176 — V-VITFREEZE and V-VITWARMVitromed GmbH·Product code MQL·2024-09-13
K240188 — Vitruvian LiposaberBlack & Black Surgical, Inc.·Product code QPB·2024-09-13
K240232 — EK D3.3 and Ultra Wide ImplantsHiossen, Inc.·Product code DZE·2024-09-13
K240544 — EpitomeeEpitomee Medical , Ltd.·Product code QFQ·2024-09-13
K240929 — Sleep Apnea Notification Feature (SANF)Apple, Inc.·Product code QZW·2024-09-13
K240977 — DenQ Sub SLA Implant SystemDenq·Product code DZE·2024-09-13
K241722 — Elos Accurate® Hybrid Base; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S·Product code NHA·2024-09-13
K241875 — TheRay Collared and Collarless Femoral StemNextstep Arthropedix·Product code MEH·2024-09-13
K242441 — Revian Lyte (10011)Revian, Inc.·Product code OAP·2024-09-13
DEN230081 — Hearing Aid Feature (HAF)Apple, Inc.·Product code SCR·2024-09-12
K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.·Product code PDJ·2024-09-12
K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L·Product code DTZ·2024-09-12
K233732 — CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics·Product code OOK·2024-09-12
K240168 — N7-SNuga Medical Co., Ltd.·Product code JFB·2024-09-12
K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 moreBiotronik, Inc.·Product code DQY·2024-09-12
K240803 — Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC·Product code DZE·2024-09-12
K240880 — VitalFlow Set with Balance BiosurfaceMedtronic, Inc.·Product code QJZ·2024-09-12
K240942 — CINA-CSpineAvicenna.Ai·Product code QAS·2024-09-12
K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)Palodex Group OY·Product code OAS·2024-09-12
K241280 — Constellation (CON-001)Q Bio, Inc.·Product code QIH·2024-09-12
K241432 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2024-09-12
K241493 — Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.·Product code EBI·2024-09-12
K241524 — Elucid PlaqueIQElucid Bioimaging, Inc.·Product code LLZ·2024-09-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.