510(k) Clearances in 2022 — Page 60

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 60 of 65)
510(k) clearancesDetails
K213824 — Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation Feb 3, 2022
K210826 — Healing Abutment, Cover ScrewMegagen Implant Co., Ltd. Feb 3, 2022
K213976 — Contour ProtégéAIMim Software, Inc. Feb 3, 2022
K203335 — MectaScrew ExtensionMedacta International S.A. Feb 3, 2022
K210832 — EVOCLEAN CLEANsert Ultrasonic InsertTtbio Corp. Feb 2, 2022
K213814 — Viveve 2.0 SystemViveve, Inc. Feb 2, 2022
K211603 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact LensesPegavision Corporation Feb 2, 2022
K203586 — EndoSerter-PLCorneagen, Inc. Feb 2, 2022
K201403 — NATtrol BD MAX Vaginal Panel External ControlsZeptometrix Feb 2, 2022
K212079 — TeesuVac Breast Biopsy Device Mark 1Teesuvac Aps Feb 2, 2022
K213554 — Sentient Manufacturing Laser FiberSentient Manufacturing , LLC Feb 2, 2022
K211228 — RossoQuanta System Spa Feb 2, 2022
K213812 — PALACOS MV proHeraeus Medical GmbH Feb 2, 2022
K220257 — Permadyne3M Deutschland GmbH Feb 1, 2022
K213565 — JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC Feb 1, 2022
K210727 — HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC Feb 1, 2022
K213830 — Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited Feb 1, 2022
K203088 — Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. Feb 1, 2022
K211701 — X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC Feb 1, 2022
K213701 — Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics Feb 1, 2022
K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd. Feb 1, 2022
K212611 — CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd. Feb 1, 2022
K220023 — 8mm Monopolar Curved ScissorsIntuitive Surgical, Inc. Jan 31, 2022
K211628 — MIS Precision Chevron Bunion SystemRelja Innovations, LLC Jan 31, 2022
K213908 — SKR 3000Konica Minolta, Inc. Jan 31, 2022
K203272 — Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. Jan 31, 2022
K213188 — Primary ReliefDyansys, Inc. Jan 31, 2022
K213401 — DIAPLUS UniversalDiaDent Group International Jan 31, 2022
K211096 — Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd. Jan 28, 2022
K213523 — X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd. Jan 28, 2022
K213082 — Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Guangzhou Berrcom Medical Device Co., Ltd. Jan 28, 2022
K203260 — syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. Jan 28, 2022
K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsAnhui Xinyisheng Medical Technology Co.,Ltd Jan 28, 2022
K214106 — QuikPass CatheterTraverse Vascular, Inc. Jan 28, 2022
K212341 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2UQura S.R.L Jan 28, 2022
K213142 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid SolutionShen Wei USA, Inc. Jan 28, 2022
K212120 — Surgical MasksHubei Xinxin Non-Woven Co., Ltd. Jan 28, 2022
K203395 — Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. Jan 28, 2022
K212533 — BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG Jan 28, 2022
K213093 — STEP-1 PumEtchRounding Third, LLC Jan 28, 2022
K212648 — VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics Jan 28, 2022
K213317 — ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd. Jan 28, 2022
K212598 — iHealth infrared Ear thermometer PT5Andon Health Co, Ltd. Jan 28, 2022
K212943 — SyntheCel Dura RepairSynthes (USA) Products, LLC Jan 28, 2022
K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc. Jan 27, 2022
K212373 — Sim&SizeSim&Cure Jan 27, 2022
K203774 — SmartAdjust technologyInsulet Corporation Jan 27, 2022
K212312 — RA-T59 Wrist blood pressure monitorLotusnine Medical Limited Jan 27, 2022
K213493 — Fortilink with TiPlus TechnologyParadigm Spine Jan 27, 2022
K213475 — Elevo Snoring Intervention SetZelegent, Inc. Jan 27, 2022
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