510(k) Clearances in 2022 — Page 47

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 47 of 65)
510(k) clearancesDetails
K213620 — ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc. Apr 22, 2022
K213708 — ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) Apr 22, 2022
K212608 — RibFix Blu Thoracic Fixation SystemBiomet Microfixation Apr 22, 2022
K203855 — CoNextions TR Tendon Repair SystemConextions Medical Apr 22, 2022
K211123 — LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelHuizhou Foryou Medical Devices Co., Ltd. Apr 22, 2022
K212090 — Electric ScooterAnhui Jbh Medical Apparatus Co., Ltd. Apr 22, 2022
K220840 — 1 Series Phototherapy EquipmentDaavlin Distributing Co. Apr 22, 2022
K213681 — Ivory Glove Powder-Free Nitrile Examination GlovesIvory Gloves Sdn. Bhd. Apr 21, 2022
K220605 — Venus Bulk Flow ONEKulzer, LLC Apr 21, 2022
K212277 — Tempo TamponDong-A Pharmaceutical Co., Ltd. Apr 21, 2022
K220175 — GM85Samsung Electronics Co., Ltd. Apr 21, 2022
K213452 — GEMS-HSamsung Electronics Co., Ltd. Apr 21, 2022
K213795 — Videa Caries AssistVideahealth, Inc. Apr 21, 2022
K212737 — INHANCE™ Reverse Shoulder SystemDepuy Ireland UC Apr 21, 2022
K213559 — FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering Apr 21, 2022
K210183 — Waterlase iPLusBiolase, Inc. Apr 21, 2022
K220382 — Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/PurpleJiangsu Bytech Medical Supplies Co., Ltd. Apr 21, 2022
K212158 — HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. Apr 21, 2022
K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development Of Medical Devices, Ltd.; Mesi D.O.O. Apr 21, 2022
K220543 — Auxo A300, A150 and APodAuxo Hair, LLC Apr 20, 2022
K212022 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company Apr 20, 2022
K220866 — EKOS+ Endovascular DeviceBoston Scientific Apr 20, 2022
K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc. Apr 20, 2022
K213484 — SmoothCool HR SystemJeisys Medical, Inc. Apr 20, 2022
K220872 — Saberscope5 LaparoscopeXenocor, Inc. Apr 20, 2022
K220149 — General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)Xera Medical Systems & Technology , Ltd. Apr 19, 2022
K212241 — QUATERA 700Carl Zeiss Meditec, AG Apr 19, 2022
K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)Hong Qiangxing (Shenzhen) Electronics Limited Apr 19, 2022
K220810 — Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International Apr 19, 2022
K211837 — Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC Apr 19, 2022
K213930 — Brainlab Elements Guide XT, Guide 3.0Brainlab AG Apr 19, 2022
K220075 — Spartan Center WireSpartan Micro, Inc. Apr 19, 2022
K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. Apr 19, 2022
K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation Apr 18, 2022
K220131 — KYPHON VuE Bone CementTecres S.P.A. Apr 18, 2022
K220871 — NautilusDornier Medtech America, Inc. Apr 18, 2022
K213408 — BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd Apr 17, 2022
K212677 — aboNT SYRINGENipro Medical Corporation Apr 15, 2022
K220946 — SURGIVISIO DeviceEcential Robotics Apr 15, 2022
K220779 — XDMirada Medical, Ltd. Apr 15, 2022
K220141 — RayStation 11BRaySearch Laboratories AB (PUBL) Apr 15, 2022
K212522 — Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC Apr 15, 2022
K212377 — Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01Ningbo Medkinetic Medical Device Co., Ltd. Apr 15, 2022
K212773 — ARDO AlyssaArdo Medical AG Apr 15, 2022
K220459 — Mako Total Knee ApplicationMako Surgical Corp. Apr 15, 2022
K213706 — AI-Rad Companion Brain MRSiemens Healthcare GmbH Apr 15, 2022
K213350 — mJOULE System and AccessoriesSciton, Inc Apr 15, 2022
K220797 — FootHold SystemCrossroads Extremity Systems, LLC Apr 15, 2022
K212163 — Coala Heart MonitorCoala Life AB Apr 14, 2022
K213959 — MagnetOs Flex MatrixKuros Biosciences B.V Apr 14, 2022
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