510(k) Clearances in 2022 — Page 51

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 51 of 65)
510(k) clearancesDetails
K212159 — Shield SystemRadiaction , Ltd. Mar 30, 2022
K213896 — BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular Mar 30, 2022
K213699 — CareTaker Monitor AppCaretaker Medical, LLC Mar 30, 2022
K210422 — INTAI Surgical Mask (non-sterile)Intai Technology Corp. Mar 30, 2022
K214047 — EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical Mar 30, 2022
K212464 — Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation Mar 30, 2022
K211681 — EONDominion Aesthetic Technologies, Inc. Mar 30, 2022
K213370 — VERIQAPtw-Freiburg Physikalisch-Technische-Werkstaetten Mar 30, 2022
K214093 — VSP Bolus3D Systems Mar 30, 2022
K213887 — GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. Mar 29, 2022
K202266 — Reliance Cervical IBF SystemReliance Medical Systems, LLC Mar 29, 2022
DEN200042 — BrainTemp Neonate System (BTNeo System)Brain Temp, Inc. Mar 29, 2022
K213529 — Focus HD 43 DetectorIray Technology Taicang , Ltd. Mar 29, 2022
K220255 — REAL INTELLIGENCE CORIBlue Belt Technologies, Inc. Mar 29, 2022
K210321 — Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation Mar 29, 2022
K220247 — Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. Mar 29, 2022
K213646 — Focus HD 35 DetectorIray Technology Taicang , Ltd. Mar 29, 2022
K213415 — OSSIOfiber Suture AnchorOSSIO , Ltd. Mar 28, 2022
K214113 — Hand-held IPL device(JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd. Mar 28, 2022
K212889 — Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. Mar 28, 2022
K213147 — CERABIEN MiLaiKuraray Noritake Dental, Inc. Mar 28, 2022
K213662 — Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)Taishan Weibang Medical Equipment Co., Ltd. Mar 28, 2022
K213672 — T3 Pro ImplantsBiomet 3I, LLC Mar 28, 2022
K212037 — SancDam Latex Oral DamSanctuary Health Sdn. Bhd. Mar 28, 2022
K210352 — GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. Mar 27, 2022
K220215 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)Ksg Medicare Sdn. Bhd. Mar 26, 2022
K213729 — Clover GloveClover Glove Company Limited Mar 26, 2022
K220229 — Powder Free Nitrile Examination Gloves, OrangeShanxi Hongjin Plastic Technology Co., Ltd. Mar 26, 2022
K212231 — C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD MonitorNanjing Jusha Display Technology Co., Ltd. Mar 25, 2022
K210037 — Pluski Safe 1 Safety IV CatheterMediplus (India) Limited Mar 25, 2022
K202437 — Infusion Sets for Single UseJiangsu Suyun Medical Materials Co., Ltd. Mar 25, 2022
K213355 — Toro-L Interbody Fusion SystemIntegrity Implants, Inc. Mar 25, 2022
K220242 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 25, 2022
K213562 — DTX Studio Clinic 3.0Nobel Biocare AB Mar 25, 2022
K220637 — 3 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply Mar 25, 2022
K213820 — BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co. , Ltd. Mar 25, 2022
K220362 — LE-12CHCaf Medical Solutions, Inc. Mar 25, 2022
K212395 — NebulizerShenzhen Homed Medical Device Co., Ltd. Mar 25, 2022
K212153 — Biobeat Platform, BB-613WP PatchBiobeat Technologies , Ltd. Mar 25, 2022
K220187 — Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd Mar 25, 2022
K213848 — Medical nitrile examination gloves (Model: JL001)Guangdong Jiali Pharmaceutical Co.,Ltd Mar 25, 2022
K212263 — Luna G3 BPAP System3B Medical, Inc. Mar 25, 2022
K220600 — Artix Thrombectomy DeviceInari Medical Mar 25, 2022
K202903 — Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd. Mar 24, 2022
K220629 — Emerge Monorail PTCA Dilatation CatheterBoston Scientific Mar 24, 2022
K213492 — Dib UltraNav Transseptal Catheter SystemDib Ultranav Medical, LLC Mar 24, 2022
K220206 — Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd Mar 24, 2022
K213589 — FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd. Mar 24, 2022
K220453 — FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. Mar 24, 2022
K220196 — Steth IO SpotStratoscientific Mar 24, 2022
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