510(k) Clearances — Page 183

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 183 of 3,525)
ClearancesDetails
K233503 — 14F iSLEEVE Introducer SetBoston Scientific Corporation Nov 30, 2023
K232155 — syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. Nov 30, 2023
K230587 — Wrist Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. Nov 30, 2023
K233552 — IDEAL ZiploopRiverpoint Medical Nov 30, 2023
K233500 — Benesta Tissue Removal DeviceCaldera Medical, Inc. Nov 30, 2023
K221787 — Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited Nov 30, 2023
K231877 — NavaClick Injection SystemLineage Biomedical, Inc. Nov 30, 2023
K233545 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC Nov 30, 2023
K231393 — Radical the Dude 7F Guide CatheterMaduro Medical, Inc. Nov 30, 2023
K231546 — SomfitCompumedics Limited Nov 30, 2023
K230726 — CEREGLIDE 92 Intermediate CatheterCerenovus, Inc. Nov 29, 2023
K230179 — 6440 MyLabX90Esaote, S.P.A. Nov 29, 2023
K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. Nov 29, 2023
K230646 — SUREcore Prime Biopsy InstrumentUro-1 Medical, Inc. Nov 29, 2023
K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC Nov 29, 2023
K232684 — Surgify HaloSurgify Medical OY Nov 29, 2023
K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLC Nov 29, 2023
K232244 — Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd. Nov 29, 2023
K232069 — Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd. Nov 29, 2023
K232033 — HYBRIDknife® flexErbe Elektromedizin GmbH Nov 29, 2023
K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)Shenzhen Plinma Technology Co. , Ltd. Nov 29, 2023
K231203 — Mosie Baby KitMosie Baby Nov 29, 2023
K233532 — MULTIX Impact ESiemens Medical Solutions Nov 29, 2023
K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Nov 28, 2023
K233493 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)Relign Corporation Nov 28, 2023
K230947 — C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc. Nov 28, 2023
K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation Nov 28, 2023
K231250 — Digital Blood Pressure MonitorGuangdong Genial Technology Co., Ltd. Nov 28, 2023
K232643 — Cue COVID-19 Molecular TestCue Health, Inc. Nov 28, 2023
K232012 — N1Osstem Implant Co., Ltd. Nov 28, 2023
K231473 — Monarch BronchoscopeAuris Health, Inc., A Johnson And Johnson Family Company Nov 28, 2023
K232595 — Kinos Axiom Total Ankle SystemRestor3D Nov 28, 2023
K232000 — syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. Nov 28, 2023
K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd. Nov 28, 2023
K230883 — VersaPump Infusion SystemEmed Technologies Corporation Nov 28, 2023
K232713 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Nov 28, 2023
K232252 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)Dehai (Shandong) Medical Gloves, Co., Ltd. Nov 28, 2023
K231631 — BriefCase-QuantificationAidoc Medical , Ltd. Nov 28, 2023
K222845 — Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC Nov 28, 2023
K232624 — CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH Nov 27, 2023
K231104 — ABPMproSomnomedics GmbH Nov 27, 2023
K233243 — ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. Nov 27, 2023
K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson And Company Nov 27, 2023
K233343 — SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC Nov 27, 2023
K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L. Nov 27, 2023
K233332 — Statera-C™ Spinal SystemK&J Consulting Corp. Nov 27, 2023
K230379 — Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. Nov 27, 2023
K232658 — T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. Nov 27, 2023
K233171 — PF Keep; Cad Cam Keep BlockClemde SA DE CV Nov 27, 2023
K231661 — CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. Nov 27, 2023
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