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Medline Industries, Inc.

FDA 510(k) & PMA Approved Devices — 75 products

Total Devices75
Categories36
Latest Approval2024-03-27
TypeNumberDevice NameCodeDate
510(k) DEN210049 Medline ART Skin Harvesting System QYK 2024-03-27 View
510(k) K230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) BTT 2023-10-26 View
510(k) K223100 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) CAF 2023-06-27 View
510(k) K222665 Medline UNITE® Ankle Fusion Plating System HRS 2023-01-25 View
510(k) K213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe FMF 2022-12-09 View
510(k) K212911 Konig Mogen Clamp HFX 2022-11-18 View
510(k) K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser BWF 2022-10-25 View
510(k) K213481 Medline General Surgery Tray LRO 2022-05-24 View
510(k) K212093 Medline Universal Grounding Pad GEI 2022-01-14 View
510(k) K213068 Medline Smoke Evacuation Shroud FYD 2022-01-03 View
510(k) K211612 Medline UNITE REFLEX Dynamic Discs HTN 2021-12-10 View
510(k) K212258 Medline Cardiovascular Procedure Kit LRO 2021-12-03 View
510(k) K211931 Medline Digital Thermometer Non-Lubricated Probe Sheath FLL 2021-09-20 View
510(k) K203538 SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO 2021-08-02 View
510(k) K211944 Medline UNITE® Digital Fusion Screw System HWC 2021-07-22 View
510(k) K203135 Medline Vacu-line Suction Aspirator BTA 2021-05-04 View
510(k) K210482 Medline UNITE REFLEX Nitinol Staple System JDR 2021-04-22 View
510(k) K202447 Medline Orbis Surgical Gown FYA 2021-04-02 View
510(k) K210526 Medline Cautery Tip Cleaner GEI 2021-03-12 View
510(k) K202668 Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein KGO 2020-12-19 View
510(k) K202449 Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein KGO 2020-11-18 View
510(k) K200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) LZA 2020-10-26 View
510(k) K202179 Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) LYZ 2020-10-26 View
510(k) K202285 Medline ENfit OTC Feeding Syringe PNR 2020-10-09 View
510(k) K201290 Medline DeNovo 4Pro Electrical Stimulation Device IPF 2020-09-21 View
510(k) K201829 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO 2020-09-09 View
510(k) K193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff LZA 2020-08-04 View
510(k) K193217 SensiCare PI and SensiCare PI Micro Surgical Gloves KGO 2020-04-06 View
510(k) K192988 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use KGO 2020-04-01 View
510(k) K191753 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) LZA 2020-03-17 View
510(k) K191915 SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V KGO 2020-03-06 View
510(k) K192820 SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) KGO 2020-02-28 View
510(k) K192641 Gemini Titan Sterilization Wrap FRG 2020-01-24 View
510(k) K192985 Medline Glide-On 3G Vinyl Examination Gloves LYZ 2020-01-21 View
510(k) K192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) LZA 2020-01-10 View
510(k) K192104 Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) LZA 2019-12-23 View
510(k) K191759 Medline Quick Switch Valve with ENFit Connector PIF 2019-12-04 View
510(k) K191378 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe NGT 2019-09-15 View
510(k) K190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) FYA 2019-07-04 View
510(k) K183431 Medline Digital Rectal Thermometer Sheath FLL 2019-06-14 View
510(k) K183335 Medline Poly-Cath Red Polymer Urethral Catheter GBM 2019-06-12 View
510(k) K190643 Medline Electrocautery Pencil GEI 2019-05-06 View
510(k) K183577 Medline Quick-Clear Wand KNT 2019-05-04 View
510(k) K182172 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) FYA 2019-04-24 View
510(k) K190224 Medline Burn and Wound Dressing (OTC) FRO 2019-03-08 View
510(k) K181782 Medline Reinforced Epidural Catheter BSO 2019-03-04 View
510(k) K182812 Medline Cautery Electrode (SILICONE) GEI 2018-12-12 View
510(k) K181820 Medline Unite Mini Plates and Screws HRS 2018-11-01 View
510(k) K181726 Medline Patient Cables and Lead Wires DSA 2018-09-20 View
510(k) K173911 Medline Burn and Wound Dressing FRO 2018-07-19 View
510(k) K173276 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP FRO 2018-07-02 View
510(k) K173348 0.9% Sodium Chloride Injection, USP NGT 2018-06-21 View
510(k) K172954 Medline Prevention CoolZone Gown FYA 2018-06-15 View
510(k) K180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) LZA 2018-04-30 View
510(k) K173889 Medline Cautery Electrode (PTFE) GEI 2018-04-09 View
510(k) K172541 Medline Catheter Specimen Collector EZD 2018-02-22 View
510(k) K173113 Medline Disposable Electronic Thermometer Probe Cover FLL 2018-01-17 View
510(k) K170002 Medline Blood Collection Set FPA 2017-09-19 View
510(k) K170415 Medline Hemo-Force DVT Compression Sleeve JOW 2017-09-08 View
510(k) K170782 Medline UNITE® Snap-Off Screws HWC 2017-08-18 View
510(k) K162993 Gemini Sterilization Wrap FRG 2017-06-23 View
510(k) K162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) LZA 2017-02-27 View
510(k) K160471 Medline Non-Surgical Isolation Gown- FYC 2017-01-31 View
510(k) K160660 Medline Waste Station DQO 2017-01-19 View
510(k) K162829 Medline UNITE® Ankle Fracture Plating System HRS 2016-12-09 View
510(k) K160642 Medline ENFit Syringe PIF 2016-11-29 View
510(k) K161473 Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) LZA 2016-10-19 View
510(k) K152564 Gemini Sterilization Wrap FRG 2016-07-07 View
510(k) K161035 Medline Singe Patient Use Blood Pressure Cuff DXQ 2016-06-13 View
510(k) K152458 Gemini Bonded Sterilization Wrap FRG 2016-06-01 View
510(k) K150598 Blockade Surgical Gown FYA 2016-04-28 View
510(k) K152428 SensiCare PI Surgical Gloves KGO 2016-03-31 View
510(k) K151754 Glide-On Vinyl Examination Gloves LYZ 2016-03-22 View
510(k) K150731 Medline Epidural Catheter BSO 2016-03-07 View
510(k) K152948 Medline Anti-Fog Solution OCT 2016-02-04 View
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