510(k) Clearances in 2022 — Page 64

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 64 of 65)
510(k) clearancesDetails
K212801 — Powder free nitrile examination glove- black, non sterileHong Seng Gloves Sdn Bhd Jan 9, 2022
K203360 — EK Implants and Abutments SystemHiossen, Inc. Jan 7, 2022
K210564 — Infrared ThermometerAlicn Medical Shenzhen, Inc. Jan 7, 2022
K212990 — Acumed Ankle Syndesmosis Repair SystemAcumed, LLC Jan 7, 2022
K213880 — Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc. Jan 7, 2022
K211742 — SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. Jan 7, 2022
K210198 — GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, StardriveGpc Medical Limited Jan 7, 2022
K210039 — CORE1 Implant SystemCybermed, Inc. Jan 7, 2022
K211349 — Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Jan 7, 2022
K211716 — DropSafe Safety Pen NeedlesHtl Strefa SA Jan 7, 2022
K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. Jan 7, 2022
K211940 — Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. Jan 7, 2022
K211110 — Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc. Jan 7, 2022
K212841 — Pectus Blu Support Bar SystemBiomet Micofixation Jan 7, 2022
K213570 — Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. Jan 7, 2022
K212980 — Tesera-k ALIF SystemKyocera Medical Technologies, Inc. Jan 7, 2022
K212152 — Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems Jan 7, 2022
K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH Jan 7, 2022
DEN210015 — Sunrise Sleep Disorder Diagnostic AidSunrise Jan 7, 2022
K212127 — PicocaremajestyWontech Co., Ltd. Jan 7, 2022
K213901 — Cyclops™ Anterior Cervical Plate SystemDegen Medical Jan 7, 2022
K213262 — CELERITY HP Chemical IndicatorSTERIS Corporation Jan 7, 2022
K211443 — AIBOLIT 3D+Aibolit Technologies, LLC Jan 7, 2022
K213720 — Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) Jan 7, 2022
K213053 — Gold AnchorNaslund Medical AB Jan 6, 2022
K212847 — Penta GlovePentavest Holdings Sdn Bhd Jan 6, 2022
K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc. Jan 6, 2022
K213839 — DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. Jan 6, 2022
K211135 — Enlight 2100Timpel S.A. Jan 6, 2022
K212797 — iPrime Viscodelivery SystemGlaukos Jan 6, 2022
K212468 — Tigereye CTO-Crossing CatheterAvinger, Inc. Jan 6, 2022
K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho Jan 6, 2022
K213841 — ENEO TOTALE (Model: ENEOT947)Premier North America, Inc. Jan 6, 2022
K213544 — TOMTEC-ARENATomtec Imaging Systems GmbH Jan 6, 2022
K211149 — Urethral Warming Catheter KitVarian Medical Systems, Inc. Jan 5, 2022
K213817 — MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. Jan 5, 2022
K212609 — BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen Of Troy Company Jan 5, 2022
K213816 — MPO Hip InstrumentsMicroport Orthopedics, Inc. Jan 5, 2022
K211318 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management PacksSmith Nephew Medical Limited Jan 5, 2022
K213951 — FORZA XP Expandable Spacer SystemOrthofix US, LLC Jan 5, 2022
K213281 — PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA Jan 5, 2022
K211978 — JplantJj Medical Co., Ltd. Jan 5, 2022
K213342 — PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc Jan 5, 2022
K213879 — Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd. Jan 5, 2022
K212115 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd. Jan 5, 2022
K213019 — Vinyl Exam GlovesHebei Astro Medical Supply Co., Ltd. Jan 5, 2022
K213344 — BTL-899ABTL Industries, Inc. Jan 5, 2022
K202994 — InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation Jan 4, 2022
K211789 — restor3d Pin ImplantsRestor3D Jan 4, 2022
K211647 — HP358EA Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. Jan 4, 2022
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