510(k) Clearances — Page 172

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 172 of 3,525)
ClearancesDetails
K233143 — PiXel8-RevealRohrer Aesthetics Feb 2, 2024
K231325 — Corplex P / Theracor P / Allacor PStimlabs, LLC Feb 2, 2024
K233531 — OIC FLEX-FIX™ SystemOrthopaedic Implant Company Feb 2, 2024
K230548 — Myoaligner ApplianceMyohealth Technologies, LLC Feb 2, 2024
K233756 — Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)Rhein Laser Technologies Co., Ltd. Feb 2, 2024
K231373 — BD Vacutainer® K2 EDTA Blood Collection TubesBecton, Dickinson And Company Feb 2, 2024
K231625 — VitalDetectWellvii, Inc. Feb 2, 2024
K233855 — AllPEPEnchant Tek Co. , Ltd. Feb 2, 2024
K233472 — CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. Feb 2, 2024
K230657 — BTL-99-OCBTL Industries, Inc. Feb 1, 2024
K233183 — Surgical Gown (40083)Ammex-Weida (Hubei) Health And Safety Products Co., Ltd. Feb 1, 2024
K232165 — Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic NeedlesBerpu Medical Technology Co., Ltd. Feb 1, 2024
K240018 — WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation Feb 1, 2024
K232949 — Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc. Feb 1, 2024
K232339 — Augmented Reality ApplicationSira Medical, Inc. Feb 1, 2024
K233804 — Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc. Feb 1, 2024
K232007 — CAAS MR SolutionsPie Medical Imaging BV Feb 1, 2024
K240025 — Clearblue® Early Detection Pregnancy TestSpd Swiss Precision Diagnostics GmbH Jan 31, 2024
DEN210035 — “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”Hologic, Inc. Jan 31, 2024
K231396 — CEPHX- Cephalometric Analysis SoftwareOrca Dental AI , Ltd. Jan 31, 2024
K214115 — MightySat -OTCMasimo Corporation Jan 31, 2024
K232678 — Digital Thermometer, Model T28, T28LGuangdong Genial Technology Co., Ltd. Jan 31, 2024
K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve SteerCirca Scientific, Inc. Jan 31, 2024
K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd. Jan 31, 2024
K232432 — E3D™-A Interbody SystemEvolution Spine Jan 30, 2024
K232986 — VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc. Jan 30, 2024
K234140 — VIVA combo RF System (VIVA combo RF System)Starmed Co., Ltd. Jan 30, 2024
K231343 — Redemption Duo Hindfoot Nail SystemVilex, LLC Jan 30, 2024
K231910 — DermRays ReviveWuhan Lotuxs Technology Co., Ltd. Jan 30, 2024
K240020 — Ziehm Vision FDZiehm Imaging GmbH Jan 30, 2024
K232942 — G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing MediaGimbo Medical Technology Shenzhen Co., Ltd. Jan 30, 2024
K230794 — Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC., Jan 29, 2024
K233394 — Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance Jan 28, 2024
K233224 — Epilaser ProEpilady 2000, LLC Jan 27, 2024
K232864 — EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IINantong Egens Biotechnology Co., Ltd. Jan 26, 2024
K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies Jan 26, 2024
K233485 — M-WaveZynex Medical, Inc. Jan 26, 2024
K232450 — Disposable Hemostatic ClipsZhejiang Soudon Medical Technology Co., Ltd. Jan 26, 2024
K234145 — ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories Jan 26, 2024
K233598 — Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsAnhui Intco Medical Products Co., Ltd. Jan 26, 2024
K231785 — Perifit PumpX6 Innovations Jan 26, 2024
K231282 — LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC Jan 26, 2024
K233299 — ExactechGPS® SystemBlue Ortho Jan 26, 2024
K231715 — MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation Jan 26, 2024
K234118 — CentriMag™ Acute Circulatory Support SystemABBOTT MEDICAL Jan 26, 2024
K231329 — Aptima Neisseria gonorrhoeae AssayHologic, Inc. Jan 26, 2024
K231303 — Arm-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd. Jan 26, 2024
K232182 — One-FilMediclus Co., Ltd. Jan 26, 2024
K233508 — iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. Jan 26, 2024
K234109 — Ziehm Solo FDZiehm Imaging GmbH Jan 26, 2024
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