510(k) Clearances — Page 144

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 144 of 3,525)
ClearancesDetails
K240616 — FAQ™ (102)Foreo, Inc. Jul 15, 2024
K233458 — CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd. Jul 15, 2024
K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG Jul 15, 2024
K241032 — BellaTek BarsBiomet 3I, LLC Jul 15, 2024
K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd. Jul 15, 2024
K240178 — RFG-01Zimmer Medizinsysteme GmbH Jul 15, 2024
K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical Jul 15, 2024
K233449 — Avantik VTMHanchang Medic Co., Ltd. (Han Chang Medic) Jul 15, 2024
K241385 — Omnifix Syringe NRFitB.Braun Medical, Inc. Jul 13, 2024
DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)Terragene S.A. Jul 12, 2024
K241018 — KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. Jul 12, 2024
K240651 — MRI UniversalStryker Leibinger GmbH & Co KG Jul 12, 2024
K240661 — Geistlich Bio-Oss®Geistlich Pharma AG Jul 12, 2024
K241031 — TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. Jul 12, 2024
K241705 — MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)Milkmate Products, Inc. Jul 12, 2024
K233457 — RUSHutom, Inc. Jul 12, 2024
K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)Megadyne Medical Products, Inc. Jul 12, 2024
K241713 — HiRise (1040-230)Curvebeam, LLC Jul 12, 2024
K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsPrismatik Dentalcraft, Inc. Jul 12, 2024
K241715 — Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. Jul 12, 2024
K241085 — Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC Jul 12, 2024
K234077 — SPIRA® Anterior Lumbar SpacersCamber Spine Technologies Jul 12, 2024
K240247 — “MoFi” Cell Culture Basal MediumDuogenic Stemcells Corporation Jul 12, 2024
K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical Jul 12, 2024
K241378 — S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A. Jul 12, 2024
K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd. Jul 12, 2024
K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical Jul 12, 2024
K241727 — BriefCase-TriageAidoc Medical , Ltd. Jul 12, 2024
K241720 — VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. Jul 12, 2024
K240920 — HemoCare Bicarbonate Concentrate Set (BCS)Deka Research And Development Jul 12, 2024
K233557 — HemoCare Hemodialysis SystemDeka Research And Development Jul 12, 2024
K233834 — Infinity Gateway SuiteDraeger Medical Systems, Inc. Jul 12, 2024
K234124 — Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd. Jul 12, 2024
K241707 — OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd. Jul 12, 2024
K241022 — Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Jul 11, 2024
K241006 — Natural CyclesNatural Cycles Nordic AB Jul 11, 2024
K241711 — Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. Jul 11, 2024
K241460 — Manual WheelchairLichtmega Technology Co., Ltd. Jul 11, 2024
K241329 — SubtleSYNTH (1.x)Subtle Medical, Inc. Jul 11, 2024
K241706 — MicroMatrix® UBM ParticulateAcell, Inc. Jul 11, 2024
K233874 — tmCMF SolutionTechmah Cmf Jul 11, 2024
K233791 — Drivewire 24 GuidewireRapid-Medical , Ltd. Jul 11, 2024
K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Jul 11, 2024
K241000 — ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;Depuy Ireland UC Jul 11, 2024
K241724 — Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc. Jul 11, 2024
K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion Systems Jul 10, 2024
K233453 — Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies Corporation Jul 10, 2024
K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation Jul 10, 2024
K241426 — GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. Jul 10, 2024
K240016 — IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd. Jul 10, 2024
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