510(k) Clearances in 2022 — Page 54

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 54 of 65)
510(k) clearancesDetails
K213687 — 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16chNeocoil, LLC Mar 11, 2022
K220425 — MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc. Mar 11, 2022
K213827 — TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)Smith & Nephew, Inc. Mar 11, 2022
K213836 — Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. Mar 11, 2022
K213957 — Demetra Dermatoscope BDEM-01Barco N.V. Mar 11, 2022
K213712 — Pectus Support Bar SystemBiomet Microfixation Mar 11, 2022
K213725 — CardIQ SuiteGE Medical Systems SCS Mar 11, 2022
K213354 — Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify CartConmed Corporation Mar 11, 2022
K213869 — EmbryoSlide+ ic8 dishVitrolife A/S Mar 11, 2022
K213615 — Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. Mar 11, 2022
K213005 — Apollo Ankle Fracture Plating SystemGlw Medical, Inc. Mar 11, 2022
K213751 — NextAR™ TKA Platform My Knee PPSMedacta International S.A. Mar 10, 2022
K213373 — Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateSmart Glove Corporation Sdn. Bhd. Mar 10, 2022
K220133 — Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. Mar 10, 2022
K212965 — Smile-100 SystemNiramai Health Analytix Private Limited Mar 10, 2022
K213486 — GLP systems TrackAbbott Laboratories Mar 10, 2022
K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC Mar 10, 2022
K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp. Mar 10, 2022
K210367 — D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd. Mar 10, 2022
K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation Mar 10, 2022
K213566 — ClearRead Xray PneumothoraxRiverain Technologies, Inc. Mar 10, 2022
K214071 — Hexa-TempSpident Co., Ltd. Mar 10, 2022
K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsChangzhou Universal Medical Equipment Co., Ltd. Mar 10, 2022
K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC Mar 10, 2022
K210341 — One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH Mar 10, 2022
K213038 — Infrared Forehead Thermometer, model: HS-9802DJiaxing Shangjia Intelligence Technology Co., Ltd. Mar 10, 2022
K212755 — SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH Mar 10, 2022
K211780 — ZEN-2090 TurboGenoray Co., Ltd. Mar 9, 2022
K212499 — BD Insulin Syringe (0.3mL)Becton, Dickinson And Company Mar 9, 2022
K220340 — Amplatzer Steerable Delivery SheathABBOTT MEDICAL Mar 9, 2022
K211155 — Auto CPAP SystemBMC Medical Co., Ltd. Mar 9, 2022
K213441 — PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. Mar 9, 2022
K220069 — 4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. Mar 9, 2022
K213851 — Disposable Medical Nitrile glovesGuangdong Xingcan Brothers Medical Technology Co.,Ltd Mar 9, 2022
K213849 — SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. Mar 9, 2022
K220096 — Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine Mar 9, 2022
K220376 — Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics Mar 9, 2022
K220374 — EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL Mar 8, 2022
K211140 — Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2Stryker Sustainability Solutions Mar 8, 2022
K214087 — Medical Face MaskHubei Medlink Healthcare Co., Ltd. Mar 8, 2022
K213741 — TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd. Mar 8, 2022
K213558 — IPL Hair Removal DeviceUlike Co., Ltd. Mar 8, 2022
K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)Stryker Sustainability Solutions Mar 8, 2022
K213434 — Elation Pulmonary Balloon Dilation CatheterMerit Medical Systems, Inc. Mar 8, 2022
K203637 — SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)Coloplast Mar 8, 2022
K212049 — Oclet TDS 1000Tendonova Corporation Mar 8, 2022
K220450 — syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. Mar 7, 2022
K220506 — SkinPen Precision SystemCrown Aesthetics Mar 7, 2022
K211639 — BTL-785WBTL Industries, Inc. Mar 7, 2022
K212356 — Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc. Mar 4, 2022
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