510(k) Clearances in 2022 — Page 18

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 18 of 65)
510(k) clearancesDetails
K213014 — Varixis Elbow SystemAuxein Medical Private Limited Oct 3, 2022
K222354 — Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd. Oct 3, 2022
K212262 — PCA Syringe SetsBaxter Healthcare Corporation Oct 3, 2022
K201237 — Velano Vascular Blood Collection AdapterVelano Vascular Oct 3, 2022
K222376 — Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co. , Ltd. Oct 3, 2022
K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsOwen Mumford, Ltd. Oct 3, 2022
K222937 — Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd. Oct 1, 2022
K200073 — AugMENTA Penile ImplantAugmenta, LLC Sep 30, 2022
K213904 — Kerecis OralKerecis Sep 30, 2022
K210478 — 8mm Monopolar Curved ScissorsIconocare Health Sep 30, 2022
K222046 — Unscented Menstrual TamponSuzhou Borage Medical Technology Co., Ltd. Sep 30, 2022
K222625 — Shield SystemRadiaction , Ltd. Sep 30, 2022
K220336 — Mg-PSZ Ceramic Femoral HeadTheken Companies Sep 30, 2022
K222090 — Safety LancetNingbo Medsun Medical Co., Ltd. Sep 30, 2022
K212316 — DoubleChek DC-1001Nasogastric Feeding Solutions, Ltd. Sep 30, 2022
K222849 — AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSteris Sep 30, 2022
K222339 — uDR 380i ProShanghai United Imaging Healthcare Co., Ltd. Sep 30, 2022
K221243 — OFNat Lubricant (L15)Suretex Limited Sep 30, 2022
K222206 — Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)Shenzhen Dongjilian Medical Tech Co., Ltd. Sep 30, 2022
K213023 — Blood Pressure Monitor(Model:Y30001)Zhangzhou Easepal Medical Science And Technology Co., Ltd. Sep 30, 2022
K220758 — e-Ortho Shoulder Software v1.1FH Industrie Sep 30, 2022
K221003 — Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEACovidien Sep 30, 2022
K222244 — Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc. Sep 30, 2022
K221378 — Nitrile Powder Free Blue Patient Examination Gloves, Non-SterileTec Gloves Industry (M) Sdn.Bhd. Sep 30, 2022
K220366 — EmbedMed3D Lifeprints UK , Ltd. Sep 30, 2022
K210567 — Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd. Sep 30, 2022
K211611 — QIR SuiteCasis Cardiac Simulation & Imaging Software Sep 30, 2022
K213034 — SpineAR SNAPSurgical Theater, Inc. Sep 29, 2022
DEN200067 — INNOVANCE VWF AcSiemens Healthcare Diagnostics Products GmbH Sep 29, 2022
K213417 — Ghost Spacer SystemLife Spine, Inc. Sep 29, 2022
K221637 — Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd. Sep 29, 2022
K222005 — S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A. Sep 29, 2022
K213716 — InnovaBurnTriad Life Sciences, Inc. Sep 29, 2022
K222353 — GM85Samsung Electronics Co., Ltd. Sep 29, 2022
K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc. Sep 29, 2022
K222383 — Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) EditionMedtronic Sofamor Danek USA, Inc. Sep 29, 2022
K221918 — ReFlow System MiniAnuncia Medical, Inc. Sep 29, 2022
K221300 — Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 29, 2022
K221496 — Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 29, 2022
K221375 — CureSight-CS100Novasight , Ltd. Sep 29, 2022
K220080 — CogNet QmTRIAGEMedcognetics, Inc. Sep 29, 2022
K222687 — Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc. Sep 29, 2022
K222605 — iFuse TORQ® Implant SystemSI-BONE, Inc. Sep 29, 2022
K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd Sep 28, 2022
K220081 — CORE-SPORTIncore Co., Ltd. Sep 28, 2022
K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)Anhui Bytech Medical Supplies Co., Ltd. Sep 28, 2022
K211902 — InnovaMatrix PDTriad Life Sciences, Inc. Sep 28, 2022
K222329 — BriefCaseAidoc Medical , Ltd. Sep 28, 2022
K222482 — AGILON XO Shoulder SystemImplantcast GmbH Sep 28, 2022
K222627 — EndoGI S-Path Biliary Stent SystemEndo GI Medical Sep 28, 2022
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