510(k) Clearances in 2023 — Page 51

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 51 of 67)
510(k) clearancesDetails
K223763 — ZeptoLink IOL Positioning SystemCentricity Vision, Inc. Apr 11, 2023
K230705 — POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. Apr 11, 2023
K230402 — ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical Apr 11, 2023
K230753 — RCT800Ray Co., Ltd. Apr 11, 2023
K223176 — Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration CanisterArgon Medical Devices, Inc. Apr 10, 2023
K230366 — Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. Apr 10, 2023
K230164 — TENS and EMS Stimulation (OTC)Changsha Yuwen Medical Equipment Co., Ltd. Apr 10, 2023
K222887 — Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorFamidoc Technology Company Limited Apr 10, 2023
K230699 — ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc. Apr 10, 2023
K230360 — IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd. Apr 10, 2023
K230695 — APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC Apr 10, 2023
DEN220033 — MISHA Knee SystemMoximed, Inc. Apr 10, 2023
K230122 — IPL Hair Removal Device, Model(s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd. Apr 10, 2023
K223550 — DMXDel Medical, Inc. Apr 10, 2023
K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty RingCorcym S.R.L. Apr 7, 2023
K222909 — Axiostat GauzeAdvamedica, Inc. Apr 7, 2023
K223052 — Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc. Apr 7, 2023
K223088 — BD SmartSite™ Needle-Free ConnectorCare Fusion Apr 7, 2023
K220456 — Elecsys FT4 IVRoche Diagnostics Apr 7, 2023
K223640 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)Axogen Corporation Apr 7, 2023
DEN210055 — The N-SWEAT PatchCandesant Biomedical, Inc. Apr 7, 2023
K223816 — Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica Apr 7, 2023
K223373 — Enivo™Aroa Biosurgery , Ltd. Apr 7, 2023
K230064 — Mazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd. Apr 7, 2023
K230658 — SKOUT® systemIterative Scopes, Inc. Apr 7, 2023
K223772 — PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH Apr 7, 2023
K230575 — Limbus ContourLimbus Ai, Inc. Apr 7, 2023
K230169 — EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis Apr 6, 2023
K230069 — S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. Apr 6, 2023
K230341 — ACRIFIXDeltamed GmbH Apr 6, 2023
K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)GE Healthcare Finland Oy Apr 6, 2023
K230313 — QUANTUM Patient Specific Instrumentation (PSI) SystemIn2Bones Sas Apr 6, 2023
K222360 — AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A. Apr 6, 2023
K223774 — Contour ProtégéAIMim Software, Inc. Apr 6, 2023
K230640 — Affinity Fusion™ Oxygenator SystemMedtronic, Inc. Apr 6, 2023
K223458 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V. Apr 6, 2023
K222023 — RayFlowHexacath Apr 6, 2023
K222739 — Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd. Apr 6, 2023
K222197 — F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd. Apr 6, 2023
K230097 — IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd. Apr 6, 2023
K223310 — Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited Apr 5, 2023
K222012 — FAQ 101Foreo, Inc. Apr 5, 2023
K214009 — D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd. Apr 5, 2023
K230035 — BioSci™ Disposable Virus Sampling TubesShenzhen Dakewe Bio-Engineering Co., Ltd. Apr 5, 2023
K230336 — CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)Light Tree Ventures Europe B.V. Apr 5, 2023
K222677 — Intermittent nelaton catheter for single useHangzhou Jimushi Meditech Co., Ltd. Apr 5, 2023
K221537 — Nightwear AlignersSmylio, Inc. Apr 5, 2023
K230689 — T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC Apr 5, 2023
K221118 — CO2 Mainstream SensorDraegerwerk AG & CO Kgaa Apr 5, 2023
K211556 — N2Megagen Implant Co., Ltd. Apr 5, 2023
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