510(k) Clearances — Page 168

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 168 of 3,525)
ClearancesDetails
K230837 — PlazMagikAgnes Medical Co., Ltd. Feb 29, 2024
K232842 — Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. Feb 29, 2024
K240244 — NPseal (Small, Medium, Large)Guard Medical, Inc. Feb 29, 2024
K240268 — Accu-Joint Hemi ImplantAccufix Surgical, Inc. Feb 29, 2024
K240051 — Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd. Feb 29, 2024
K232765 — MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc. Feb 29, 2024
K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd Feb 29, 2024
K233360 — Curiteva Thoracolumbar Plate SystemCuriteva, Inc. Feb 29, 2024
K232971 — APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC Feb 29, 2024
K232562 — PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. Feb 28, 2024
K233830 — OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. Feb 28, 2024
K233488 — Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. Feb 28, 2024
DEN230024 — Technozym ADAMTS13 ActivityTechnoclone Herstellung Von Diagnostika Und Arzneimitteln GM Feb 28, 2024
K232613 — CT CardiomegalyInnolitics, LLC Feb 28, 2024
K232885 — Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd Feb 28, 2024
K231845 — Dental unit Model: MareFoshan Safety Medical Equipment Co., Ltd. Feb 28, 2024
K233623 — Praxiject™ SP 0.9% NaClMedxl, Inc. Feb 27, 2024
K233972 — Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies Feb 27, 2024
K233435 — Peace N Quiet (0.7.0)Pnq Health Feb 27, 2024
K222400 — Coresculpt & MagsculptK1Med Co., Ltd. Feb 27, 2024
K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)Maquet Cardiovascular, LLC Feb 27, 2024
K232522 — ARK Levetiracetam II AssayArk Diagnostics, Inc. Feb 27, 2024
K234014 — Obsidian® NOWPrismatik Dentalcraft, Inc. Feb 27, 2024
K232607 — 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEMSolco Biomedical Copany India Private Limited Feb 27, 2024
K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science And Technology Co., Ltd. Feb 26, 2024
K233560 — Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric AcidEco Medi Glove Sdn. Bhd. Feb 26, 2024
K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc. Feb 26, 2024
K233675 — FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc. Feb 26, 2024
K232628 — VADER® Pedicle SystemIcotec AG Feb 26, 2024
K230693 — BIS™ Advance Monitoring SystemCovidien, LLC Feb 26, 2024
K231822 — GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc. Feb 26, 2024
K232084 — Stellaris Elite vision enhancement systemBausch And Lomb Feb 26, 2024
K234133 — Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. Feb 26, 2024
K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)Shenzhen Konmed Technology Co., Ltd. Feb 23, 2024
K232800 — Navigation Tracking InstrumentsSI-BONE, Inc. Feb 23, 2024
K232536 — Soldier MicrocatheterEmbolx, Inc. Feb 23, 2024
K240213 — Iconix Knotless AnchorRiverpoint Medical Feb 23, 2024
K233754 — AIO BreatheAiomega, LLC Feb 23, 2024
K240201 — PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. Feb 23, 2024
K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care Feb 23, 2024
K230423 — Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd. Feb 23, 2024
K233722 — RADspeed ProShimadzu Corporation Feb 23, 2024
K240011 — Lymphedema CompressionJkh Health Co., Ltd. Feb 23, 2024
K233590 — Overjet Charting AssistOverjet, Inc. Feb 23, 2024
K233709 — Exceed UnlimitedMt. Derm GmbH Feb 23, 2024
K232075 — StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation Feb 23, 2024
K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoGenoss Co., Ltd. Feb 23, 2024
K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia Feb 23, 2024
K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronic Feb 23, 2024
K233995 — Ivotion Base PrintIvoclar Vivadent, Inc. Feb 23, 2024
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