510(k) Clearances in 2023 — Page 7

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 7 of 67)
510(k) clearancesDetails
K231179 — Slinky CatheterAnoxia Medical, Inc. Dec 1, 2023
K232093 — Woo More Play Coconut Love OilWoo Essentials, Inc. Dec 1, 2023
K231817 — AlignerFlow LCVoco GmbH Dec 1, 2023
K232418 — Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd. Dec 1, 2023
K232438 — Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. Dec 1, 2023
K230988 — Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. Dec 1, 2023
K232856 — Syngo Carbon ClinicalsSiemens Healthcare GmbH Dec 1, 2023
K230621 — LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. Dec 1, 2023
K230639 — Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC Dec 1, 2023
K232708 — Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd. Dec 1, 2023
K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd. Dec 1, 2023
K231211 — Medline ComfortTemp Patient Warming SystemMedline Industries, LP Dec 1, 2023
K232262 — LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )Surgease Innovations Limited Nov 30, 2023
K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc. Nov 30, 2023
K230669 — L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices Nov 30, 2023
K230061 — Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Nov 30, 2023
K232716 — Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd. Nov 30, 2023
K232709 — Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. Nov 30, 2023
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
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