510(k) Clearances in 2022 — Page 48

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 48 of 65)
510(k) clearancesDetails
K220510 — Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. Apr 14, 2022
K220561 — Disposable Medical Nitrile Examination GlovesNanjing Universal Medical Equipment Co., Ltd. Apr 14, 2022
K214053 — Amputee Garment for use with Lympha Press Optimal PlusMego Afek AC , Ltd. Apr 14, 2022
K220767 — TeleScanBb Imaging Apr 14, 2022
K220252 — High Retention Attachment SystemZest Anchors, LLC Apr 14, 2022
K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc. Apr 14, 2022
K213181 — CARESCAPE B650, E-musbGE Healthcare Finland Oy Apr 13, 2022
K211090 — ZENEX Implant SystemIzenimplant Co., Ltd. Apr 13, 2022
K210146 — Cannulated Compression Device SystemOrthopedic Designs North America, Inc. Apr 13, 2022
K212245 — Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw PlanningBrainlab AG Apr 13, 2022
K220373 — Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)Summit Glove, Inc. Apr 13, 2022
K212202 — WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemOTU Medical, Inc. Apr 13, 2022
K213133 — Keffort (MC-100, MC-100A)Oriental Inspiration Limited Apr 13, 2022
K212260 — Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. Apr 13, 2022
K220556 — OpenSensorX SeriesDentimax, Inc. Apr 13, 2022
K214051 — Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria E Comércio De Materiais Dentários S.A. Apr 13, 2022
K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic Vascular Apr 13, 2022
K210634 — MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH Apr 13, 2022
K203842 — Bendit21 MicrocatheterBend IT Technologies, Ltd. Apr 13, 2022
K210419 — BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation Apr 13, 2022
K220375 — Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)Summit Glove, Inc. Apr 13, 2022
K210148 — Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. Apr 13, 2022
K213336 — Carescape B850, E-musbGE Healthcare Finland Oy Apr 13, 2022
K213363 — CARESCAPE B450, E-musbGE Healthcare Finland Oy Apr 13, 2022
K220027 — Audion ET dilation systemEntellus Medical, Inc. Apr 12, 2022
K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Apr 12, 2022
K214040 — ClearPoint Array System (version 1.1)ClearPoint Neuro, Inc. Apr 12, 2022
K213296 — Anprolene SteriTest RRBIAndersen Sterilizers, Inc. Apr 12, 2022
K213650 — ThermPix Thermovisual CameraUsa Therm, Inc. Apr 12, 2022
K214088 — Disposable Surgical GownWeihai Hongyu Nonwoven Fabric Products Co., Ltd. Apr 12, 2022
K213398 — EMBOLD Fibered Detachable Coil SystemBoston Scientific Corporation Apr 12, 2022
K213518 — CARESCAPE CO2 Microstream parameterCovidien, LLC Apr 12, 2022
K214010 — Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA Apr 12, 2022
K220103 — LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd. Apr 12, 2022
K220405 — Amis K LongMedacta International S.A. Apr 12, 2022
K212811 — Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC Apr 12, 2022
K214025 — PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL Apr 12, 2022
K213557 — FinexelSNJ Co., Ltd. Apr 12, 2022
K213234 — CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201Ge Medical Systems Information Technologies, Inc. Apr 12, 2022
K220209 — Powder Free Nitrile Examination Glove, Non-sterile (Blue)Ksg Medicare Sdn. Bhd. Apr 11, 2022
K212719 — Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd. Apr 11, 2022
K214107 — XO CROSS CORONARY Support CatheterTransit Scientific, LLC Apr 11, 2022
K212962 — TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC Apr 11, 2022
K213675 — MP Reconstruction SystemWaldemar Link GmbH & Co. KG Apr 11, 2022
K213437 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsCentral Medicare Sdn Bhd Apr 11, 2022
K212881 — Intense Pulsed Light (IPL) SystemShenzhen Fansizhe Science And Technology Co., Ltd. Apr 11, 2022
K220477 — Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies Apr 11, 2022
K220737 — World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)Signature Orthopaedics Pty, Ltd. Apr 11, 2022
K220121 — Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and BlackAamedix Glove Sdn Bhd Apr 11, 2022
K220158 — G-EYE SystemSmart Medical Systems , Ltd. Apr 11, 2022
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