510(k) Clearances in 2022 — Page 42

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 42 of 65)
510(k) clearancesDetails
K213800 — Artiglass NRFitTM Tip L.O.R. Glass SyringesArtiglass Srl May 19, 2022
K210983 — BD Epilor SyringeBecton, Dickinson And Company May 19, 2022
K220333 — Medline Orbis LVL 3 Surgical GownMedline Industries, LP May 18, 2022
K220917 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri-Alleset, Inc. May 18, 2022
K220468 — BENCOX Mirabo Cup SystemCorentec Co., Ltd. May 18, 2022
K220211 — Nitrile Powder Free Examination GlovesHebei Kangxida Medical Technology Development Co., Ltd. May 18, 2022
K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)Pt. Maja Agung Latexindo May 18, 2022
K220463 — Osteotomy Truss System (OTS)4Web Medical, Inc. May 18, 2022
K212416 — WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203Wenzhou Xikang Medical Instruments Co., Ltd. May 18, 2022
K220467 — The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesLumenis Be, Ltd. May 18, 2022
K214120 — GSS610N21 Series Steam SterilizerMaquet GmbH May 18, 2022
K213840 — MolecuLight I:XMolecuLight, Inc. May 18, 2022
DEN210046 — Quell-FMNeurometrix, Inc. May 18, 2022
K220218 — Siren SGTTools For Surgery, LLC May 18, 2022
K220168 — Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO , Ltd. May 17, 2022
K212761 — Biocore9 Acetabular Cup SystemBiocore9, LLC May 17, 2022
K213787 — Monaco RTP SystemElekta Solutions AB May 17, 2022
K220499 — Rapid PE Triage and Notification (PETN)Ischemaview, Inc. May 17, 2022
K220516 — CATALYS Precision Laser systemAmo Manufacturing USA, LLC May 17, 2022
K221240 — BriefCaseAidoc Medical , Ltd. May 17, 2022
K220919 — MULTIX Impact ESiemens Medical Solutions USA, Inc. May 17, 2022
K220807 — Imperative Care Radial 088 Access SystemImperative Care, Inc. May 17, 2022
K220194 — Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd. May 17, 2022
K211396 — Neoss Individual ProstheticsNeoss, Ltd. May 17, 2022
K212527 — Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc. May 17, 2022
K210548 — Medline Integrated Arterial CatheterCenturion Medical Products May 17, 2022
DEN210044 — CERAMENT GBonesupport AB May 17, 2022
K220372 — Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. May 17, 2022
K221219 — syngo.CT CaScoringSiemens Medical Solutions USA, Inc. May 17, 2022
K212782 — SternaLock Sternal Closure SystemBiomet Microfixation May 17, 2022
K220404 — STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc. May 16, 2022
K213832 — AAMI3 Isolation GownHubei Xinxin Non-Woven Co., Ltd. May 16, 2022
K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. May 16, 2022
K211665 — SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd. May 16, 2022
K220669 — IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd. May 16, 2022
K212376 — Caas QardiaPie Medical Imaging BV May 16, 2022
K210516 — Clicky CrossYomura Technologies, Inc. May 16, 2022
K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd. May 14, 2022
K220626 — Introcan Safety IV CatheterB.Braun Medical, Inc. May 14, 2022
K213203 — Provena(TM) Midline CatheterC.R. Bard, Inc. May 13, 2022
K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc. May 13, 2022
K212875 — Spectral CT on RailsPhilips Medical Systems Nederland B.V. May 13, 2022
K221174 — Telepack +Karl Storz Endoscopy America, Inc. May 13, 2022
K220186 — Zone Specific AIMConmed Corporation May 13, 2022
K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited May 13, 2022
K221116 — XACT ACE Robotic SystemXact Robotics, Ltd. May 13, 2022
K221115 — Flow-NailFlow-Fx, LLC May 13, 2022
K213137 — INTDoseCarina Medical, LLC May 13, 2022
K213119 — Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. May 13, 2022
K221106 — Quantib ProstateQuantib B.V. May 13, 2022
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