510(k) Clearances in 2023 — Page 26

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 26 of 67)
510(k) clearancesDetails
K231183 — Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. Aug 25, 2023
K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC Aug 25, 2023
K231872 — Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)Kirwan Surgical Products, LLC Aug 25, 2023
K230364 — VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) Aug 25, 2023
K223898 — VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) Aug 25, 2023
K231994 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mLThermo Fisher Scientific Aug 25, 2023
K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson And Company Aug 25, 2023
K230566 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd. Aug 25, 2023
K222786 — 072 Aspiration SystemQ'Apel Medical, Inc. Aug 25, 2023
K231903 — Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc. Aug 25, 2023
K230409 — Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd. Aug 25, 2023
K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC Aug 25, 2023
K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/S Aug 25, 2023
K231255 — NovoFine® PlusNovo Nordisk, Inc. Aug 25, 2023
K223600 — Sterilization WrapWuhan Zonsen Medical Products Co., Ltd. Aug 25, 2023
K223807 — Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd Aug 25, 2023
K232214 — OMNI Surgical SystemSight Sciences, Inc. Aug 25, 2023
K230165 — Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)Coloplast Aug 25, 2023
K231599 — Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG Aug 24, 2023
K231944 — CATAMARAN SI Joint Fusion SystemTenon Medical, Inc. Aug 24, 2023
K222103 — Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. Aug 24, 2023
K231680 — AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. Aug 24, 2023
K230976 — Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. Aug 24, 2023
K231604 — Instrument CaseCochlear Americas Aug 24, 2023
K223150 — APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd. Aug 24, 2023
K231557 — ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd. Aug 24, 2023
K232215 — Quantra Hemostasis AnalyzerHemosonics, LLC Aug 24, 2023
K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, Inc. Aug 24, 2023
K223607 — Plum Duo™ Infusion SystemIcu Medical, Inc. Aug 24, 2023
K220145 — Monaghan medical filtered mouthpiece kitMonaghan Medical Corporation Aug 24, 2023
K231274 — Natural CyclesNatural Cycles Nordic AB Aug 24, 2023
K223606 — LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. Aug 24, 2023
K232291 — Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH Aug 24, 2023
K232218 — Zenius™ Spinal SystemMedyssey USA, Inc. Aug 24, 2023
K231506 — Current Health SystemCurrent Health , Ltd. Aug 24, 2023
K212766 — Maxiocel Chitosan Wound DressingAdvamedica, Inc. Aug 24, 2023
K230812 — Withings Scan Monitor 2.0Withings Aug 23, 2023
K231517 — VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics Aug 23, 2023
K232243 — EVO 700 series high speed handpieceTtbio Corp. Aug 23, 2023
K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialAnsell Healthcare Products, LLC Aug 23, 2023
K222946 — Oneday Mini Implant SystemOneday Biotech Co., Ltd. Aug 23, 2023
K223590 — Access Folate AssayBeckman Coulter, Inc. Aug 23, 2023
K230610 — Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)Dongguan Shin YI Healthcare Products Factory Aug 23, 2023
K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC Aug 22, 2023
K231503 — CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc. Aug 22, 2023
K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterMedtronic Vascular Aug 22, 2023
K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)Philips Medizin Systeme Boeblingen GmbH Aug 22, 2023
K231510 — Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd. Aug 22, 2023
DEN220052 — BrachyGel Vaginal Hydrogel Packing SystemBrachyfoam, Inc. D/B/A Advaray Aug 22, 2023
K231811 — Zavation Connector SystemZavation Medical Products, LLC Aug 22, 2023
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