510(k) Clearances — Page 173

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 173 of 3,525)
ClearancesDetails
K233735 — ADIRA™ Lateral Plate SystemGlobus Medical, Inc. Jan 25, 2024
K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)Sutter Medizintechnik GmbH Jan 25, 2024
K233893 — AlphaVent Knotless SP PEEK AnchorStryker Endoscopy Jan 25, 2024
K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV BlockerCooperVision, Inc. Jan 25, 2024
K233714 — BreViewGE Medical Systems SCS Jan 25, 2024
K232665 — GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)Convatec Jan 25, 2024
K232417 — MR Q; MR Q SUPINE; MR Q SLTMeridian AG Jan 25, 2024
K232912 — Facet Aurora Reusable Lancet BaseFacet Technologies, LLC Jan 25, 2024
K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd. Jan 24, 2024
K233195 — Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation Jan 24, 2024
K231607 — Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited Jan 24, 2024
K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB Jan 24, 2024
K231305 — Endoform Dental MembraneAroa Biosurgery , Ltd. Jan 23, 2024
K232676 — Dental Porcelain PowderChengdu Besmile Medical Technology Co., Ltd. Jan 23, 2024
K230836 — SchurSign Tissue MarkerSurgmark GmbH Jan 23, 2024
K232917 — Chemo MouthpieceChemo Mouthpiece, LLC Jan 23, 2024
K231187 — Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation Jan 23, 2024
K233013 — 2-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation Jan 23, 2024
K232673 — Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. Jan 23, 2024
K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl Jan 22, 2024
K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)Shenzhen Roundwhale Technology Co. , Ltd. Jan 22, 2024
K234087 — restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D Jan 22, 2024
K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown ScrewMegagen Implant Co., Ltd. Jan 22, 2024
K233887 — IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)Shenzhen Ulike Smart Electronics Co., Ltd. Jan 22, 2024
K230841 — NailLiftJps Corporation Jan 22, 2024
K233105 — RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. Jan 20, 2024
K230817 — TORPEDO Implant System®Deltacor GmbH Jan 19, 2024
K232347 — MagnetOs GranulesKuros Biosciences B.V Jan 19, 2024
K232783 — Power wheelchair (Model: JMPW-01W)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Jan 19, 2024
K231237 — BD Vacutainer® Fluoride Blood Collection TubesBecton, Dickinson And Company Jan 19, 2024
K231873 — DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalDepuy Ireland UC Jan 19, 2024
K232679 — Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration CanisterArgon Medical Devices, Inc. Jan 19, 2024
K233436 — IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. Jan 19, 2024
K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)Hi-Dow International, Inc. Jan 19, 2024
K233736 — LifeSPARC SystemCardiacassist, Inc. Jan 19, 2024
K233728 — SIGNA ChampionGe Healthcare (Tianjin) Company Limited Jan 19, 2024
K231071 — Mix2Vial® Transfer DeviceWest Pharma. Services IL, Ltd. Jan 19, 2024
K231213 — HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd. Jan 19, 2024
K230133 — PlenityGelesis, Inc. Jan 19, 2024
K231192 — RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation Jan 19, 2024
DEN220009 — VerTouch Spinal Imaging DeviceIntuitap Medical, Inc. Jan 19, 2024
K231218 — Distal Access CatheterAccumedical Beijing , Ltd. Jan 19, 2024
K233142 — EndoSign® Cell collection device (ES-CYT-102)Cyted Limited Jan 19, 2024
K232466 — Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. Jan 19, 2024
K232156 — Rapid ASPECTS (v3)Ischemaview, Inc. Jan 19, 2024
K230524 — Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd Jan 19, 2024
K233190 — ENFit AdaptorJiangsu Caina Medical Co.,Ltd Jan 18, 2024
K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe ElectrodesZmi Electronics , Ltd. Jan 18, 2024
K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax Of America, Inc. Jan 18, 2024
K231573 — ThinkQA (Edition 2)Dosisoft SA Jan 18, 2024
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