510(k) Clearances — Page 134

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 134 of 3,525)
ClearancesDetails
K241710 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company Sep 12, 2024
K241493 — Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc. Sep 12, 2024
K240880 — VitalFlow Set with Balance BiosurfaceMedtronic, Inc. Sep 12, 2024
K240168 — N7-SNuga Medical Co., Ltd. Sep 12, 2024
K240942 — CINA-CSpineAvicenna.Ai Sep 12, 2024
K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)Biotronik, Inc. Sep 12, 2024
K241582 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)Canon Medical Systems Corporation Sep 12, 2024
DEN230081 — Hearing Aid Feature (HAF)Apple, Inc. Sep 12, 2024
K242136 — Electric wheelchair (C001)Zhejiang Hfizer Medical Equipment Co., Ltd. Sep 12, 2024
K242401 — EXULT Knee Replacement SystemCorentec Co., Ltd. Sep 12, 2024
K241432 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 12, 2024
K233732 — CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired By Allergan Aesthetics Sep 12, 2024
K241745 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)Ksg Medicare Sdn. Bhd. Sep 11, 2024
K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc. Sep 11, 2024
K240683 — Rx Knee SystemSignature Orthopaedics Pty, Ltd. Sep 11, 2024
K241380 — FETOLY-HEARTDiagnoly Sep 11, 2024
K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek Sep 11, 2024
K241438 — Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH Sep 11, 2024
K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc. Sep 11, 2024
K241954 — SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie Sep 11, 2024
K232559 — C&B NFH HybridArum Dentistry Co., Ltd. Sep 11, 2024
K241161 — Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound ImagingLeltek, Inc. Sep 11, 2024
K241004 — Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)Huizhou Lvb Maternal And Infant Supplies Co., Ltd. Sep 11, 2024
K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. Sep 10, 2024
K240094 — LumiNE US; LumiAugmedit B.V. Sep 10, 2024
K240990 — Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd Sep 10, 2024
K241609 — Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.) Sep 10, 2024
K241214 — ProPel SG3™ Surgical GownStandard Textile Co., Inc. Sep 10, 2024
K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service And Savings, Inc. Sep 10, 2024
K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. Sep 10, 2024
K241678 — TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd. Sep 9, 2024
K240233 — Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt. , Ltd. Sep 9, 2024
K242042 — TriALTIS™ Spine SystemMedos International SARL Sep 9, 2024
K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)Shenzhen Ulike Smart Electronics Co., Ltd. Sep 9, 2024
K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)Rayence Co., Ltd. Sep 9, 2024
K242349 — FoLixLumenis Be, Ltd. Sep 9, 2024
K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited Sep 9, 2024
K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. Sep 9, 2024
K241681 — Overjet Image Enhancement AssistOverjet, Inc. Sep 9, 2024
K240791 — ADAS 3DAdas3D Medical S.L. Sep 9, 2024
K240486 — PM2 System and ECGuide ConnectorPiccolo Medical, Inc. Sep 8, 2024
K233974 — Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV Sep 6, 2024
K242415 — TMC Compression Implant SystemTreace Medical Concepts Sep 6, 2024
K233900 — Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation Sep 6, 2024
K234044 — ACS® LD FB Knee SystemImplantcast GmbH Sep 6, 2024
K241672 — COPRO 3Amt Engineering Co., Ltd. Sep 6, 2024
K241976 — nextaro® va, 15mm, 5µmSfm Medical Devices GmbH Sep 6, 2024
K241415 — Orchid Safety Release Valve™Linear Health Sciences, LLC Sep 6, 2024
K233911 — VISULAS combiCarl Zeiss Meditec, AG Sep 6, 2024
K241164 — IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) Sep 6, 2024
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