510(k) Clearances — Page 161

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 161 of 3,525)
ClearancesDetails
K232147 — CAAS WorkstationPie Medical Imaging BV Apr 9, 2024
K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMEver Fortune.Ai, Co., Ltd. Apr 8, 2024
K240423 — TDM Anterior Cervical Plate SystemTdm Co., Ltd. Apr 8, 2024
K240021 — Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl CitrateYue Kang Anhui Medical Products Co., Ltd. Apr 8, 2024
K231728 — BiWaze Clear SystemAbmrc, LLC Apr 8, 2024
K212878 — Sample preservation solutionZhejiang Gene Science Co., Ltd. Apr 8, 2024
K234152 — ACESO Early Pregnancy TestAceso Laboratories, Inc. Apr 5, 2024
K240647 — Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) Apr 5, 2024
K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A. Apr 5, 2024
K233935 — DigiLine Direct Print Aligner SystemPark Dental Research Corporation Apr 5, 2024
K234105 — Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. Apr 5, 2024
DEN210058 — ELEOSx™ Limb Salvage SystemOnkos Surgical Apr 5, 2024
K232115 — TDM Large Bone Plate and Screw SystemTdm Co., Ltd. Apr 5, 2024
K240737 — G Surgical Marksman MIS SystemG Surgical, LLC Apr 5, 2024
K232919 — Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S Apr 5, 2024
K233249 — APPRAISE-HRIThe Surgeon General, Department Of The Army (TSG-DA) Apr 5, 2024
K233666 — CorVista System with PH Add-OnAnalytics For Life, Inc. Apr 5, 2024
DEN220015 — Orthobond Mariner Pedicle Screw SystemOrthobond Coporation Apr 5, 2024
K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)MacroLux Medical Technology Co., Ltd. Apr 5, 2024
K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)Icotec AG Apr 5, 2024
K233192 — Wireless Smart ThermometerFamidoc Technology Company Limited Apr 5, 2024
K232823 — MCG-S (AM1000)Amcg Co., Ltd. Apr 5, 2024
K223914 — ACTIV™ CapCleansite Medical, Inc. Apr 5, 2024
K240360 — Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. Apr 5, 2024
DEN230032 — Symani Surgical SystemMmi North America, Inc. Apr 5, 2024
K240652 — Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Shenzhen Ulike Smart Electronics Co., Ltd. Apr 4, 2024
K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. Apr 4, 2024
K232114 — TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc. Apr 4, 2024
K232227 — ABLATE-IQNeuwave Medical, Inc. Apr 4, 2024
K240639 — PINNACLETM Constrained Acetabular LinersDepuy Ireland UC Apr 4, 2024
K231834 — VSP PEEK Cranial Implant3D Systems, Inc. Apr 4, 2024
K240038 — Clear Moves AlignersSpace Maintainers Laboratories (Sml) Apr 4, 2024
K233837 — Agile Esophageal Stent SystemBoston Scientific Corporation Apr 4, 2024
K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerMidmark Corporation Apr 4, 2024
K232790 — KONG®-TL VBR System and KONG® C VBR SystemIcotec AG Apr 4, 2024
K240071 — Peleton Universal Single Use Power System and AttachmentsPeleton Surgical Apr 4, 2024
K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia Apr 4, 2024
K233910 — Vertex Hip Fracture Nailing SystemOrthoxel Dac Apr 4, 2024
K240172 — Preview ShoulderGenesis Software Innovations Apr 4, 2024
K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC Apr 4, 2024
K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. Apr 4, 2024
K233548 — Uresta®Resilia, Inc. Apr 3, 2024
K230889 — Digital ThermometerWenzhou Yosun Medical Technology Co.,Ltd Apr 3, 2024
K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC Apr 3, 2024
K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)Dongguan Boyuan Intelligent Technology Co.,Ltd Apr 3, 2024
K240350 — AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. Apr 3, 2024
K240135 — Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc. Apr 3, 2024
K233618 — Oxevision Sleep DeviceOxehealth Limited Apr 3, 2024
K240618 — Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. Apr 3, 2024
K232899 — AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. Apr 3, 2024
← Previous Page 161 of 3525 Next →