FDA 510(k) Applications Submitted by Medline Industries, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K202179 08/04/2020 Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industries, Inc.
K202447 08/26/2020 Medline Orbis Surgical Gown Medline Industries, Inc.
K040097 01/20/2004 MEDLINE STRIDER MIDI 3 MEDLINE INDUSTRIES, INC.
K040517 02/27/2004 TENDERWET ACTIVE MEDLINE INDUSTRIES, INC.
K040818 03/30/2004 MEDLINE STRIDER MINI 3 MEDLINE INDUSTRIES, INC.
K041054 04/23/2004 MEDLINE STRIDER MAXI 3 MEDLINE INDUSTRIES, INC.
K031686 06/02/2003 AEROMIST LT, MODEL HCS15004 MEDLINE INDUSTRIES, INC.
K031843 06/16/2003 MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC.
K032446 08/08/2003 MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4 MEDLINE INDUSTRIES, INC.
K042763 10/05/2004 MODIFICATION TO MEDLINE STRIDER MIDI 3 MEDLINE INDUSTRIES, INC.
K023432 10/15/2002 MEDLINE ASEP PLUS SURGICAL DRAPES MEDLINE INDUSTRIES, INC.
K013761 11/13/2001 MEDLINE EXCEL RECLINCER WHEELCHAIR MEDLINE INDUSTRIES, INC.
K173911 12/22/2017 Medline Burn and Wound Dressing Medline Industries, Inc.
K962095 05/28/1996 MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES MEDLINE INDUSTRIES, INC.
K962076 05/28/1996 MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) MEDLINE INDUSTRIES, INC.
K962094 05/28/1996 MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES MEDLINE INDUSTRIES, INC.
K962096 05/28/1996 MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES MEDLINE INDUSTRIES, INC.
K962069 05/28/1996 MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES MEDLINE INDUSTRIES, INC.
K993170 09/22/1999 MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K042164 08/11/2004 SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) MEDLINE INDUSTRIES, INC.
K970946 03/14/1997 MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET MEDLINE INDUSTRIES, INC.
K972887 08/05/1997 MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG MEDLINE INDUSTRIES, INC.
K964142 10/16/1996 MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS MEDLINE INDUSTRIES, INC.
K965107 12/20/1996 MEDLINE ADMISSION KITS MEDLINE INDUSTRIES, INC.
K190224 02/05/2019 Medline Burn and Wound Dressing (OTC) Medline Industries, Inc.
K191753 07/01/2019 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) Medline Industries, Inc.
K181782 07/03/2018 Medline Reinforced Epidural Catheter Medline Industries, Inc.
K192104 08/05/2019 Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) Medline Industries, Inc.
K192315 08/26/2019 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc.
K173276 10/12/2017 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Medline Industries, Inc.
K150238 02/02/2015 SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color MEDLINE INDUSTRIES, INC.
K181726 06/29/2018 Medline Patient Cables and Lead Wires Medline Industries, Inc.
K191759 07/01/2019 Medline Quick Switch Valve with ENFit Connector Medline Industries, Inc.
K202285 08/12/2020 Medline ENfit OTC Feeding Syringe Medline Industries, Inc.
K172541 08/23/2017 Medline Catheter Specimen Collector Medline Industries, Inc.
K213054 09/22/2021 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe Medline Industries, Inc.
K173113 09/29/2017 Medline Disposable Electronic Thermometer Probe Cover Medline Industries, Inc.
K183335 12/03/2018 Medline Poly-Cath Red Polymer Urethral Catheter Medline Industries, Inc.
K183431 12/11/2018 Medline Digital Rectal Thermometer Sheath Medline Industries, Inc.
K183577 12/21/2018 Medline Quick-Clear Wand Medline Industries, Inc.
K210482 02/19/2021 Medline UNITE REFLEX Nitinol Staple System Medline Industries, Inc.
K170782 03/15/2017 Medline UNITE« Snap-Off Screws Medline Industries, Inc.
K150698 03/18/2015 Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC.
K040841 04/01/2004 POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC.
K151235 05/11/2015 Medline Foot Plates and Screws MEDLINE INDUSTRIES, INC.
K211612 05/26/2021 Medline UNITE REFLEX Dynamic Discs Medline Industries, Inc.
K211944 06/23/2021 Medline UNITE« Digital Fusion Screw System Medline Industries, Inc.
K151754 06/29/2015 Glide-On Vinyl Examination Gloves MEDLINE INDUSTRIES, INC.
K201829 07/02/2020 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc.
K181820 07/09/2018 Medline Unite Mini Plates and Screws Medline Industries, Inc.
K152428 08/26/2015 SensiCare PI Surgical Gloves MEDLINE INDUSTRIES, INC.
K202449 08/26/2020 Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm▓ per glove of Extractable Protein Medline Industries, Inc.
K222665 09/06/2022 Medline UNITE« Ankle Fusion Plating System Medline Industries, Inc.
K152564 09/09/2015 Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC.
K202668 09/14/2020 Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm2 per Glove of Extractable Protein Medline Industries, Inc.
K192641 09/24/2019 Gemini Titan Sterilization Wrap Medline Industries, Inc.
K052833 10/06/2005 GORE-TEX NON-STERILE SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K192988 10/25/2019 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use Medline Industries, Inc.
K162982 10/26/2016 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc.
K162993 10/27/2016 Gemini Sterilization Wrap Medline Industries, Inc.
K143322 11/19/2014 Medline Natural Lubricating Liquid MEDLINE INDUSTRIES, INC.
K193217 11/21/2019 SensiCare PI and SensiCare PI Micro Surgical Gloves Medline Industries, Inc.
K203538 12/03/2020 SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc.
K143529 12/12/2014 UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer MEDLINE INDUSTRIES, INC.
K152458 08/28/2015 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC.
K211931 06/22/2021 Medline Digital Thermometer Non-Lubricated Probe Sheath Medline Industries, Inc.
K203135 10/19/2020 Medline Vacu-line Suction Aspirator Medline Industries, Inc.
K001937 06/26/2000 MEDLINE ELECTRONIC POSITIONING CHAIR MEDLINE INDUSTRIES, INC.
K962826 07/19/1996 MEDLINE RADIOLOGY-DIAGNOSTIC KITS MEDLINE INDUSTRIES, INC.
K032666 08/28/2003 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES MEDLINE INDUSTRIES, INC.
K970286 01/24/1997 PRESBYTERIAN LINEN SERVICES SURGICAL PACKS MEDLINE INDUSTRIES, INC.
K060456 02/22/2006 MEDLINE COLLAGEN WOUND DRESSING MEDLINE INDUSTRIES, INC.
K971208 04/02/1997 MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS MEDLINE INDUSTRIES, INC.
K991559 05/04/1999 MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD MEDLINE INDUSTRIES, INC.
K061275 05/08/2006 MEDLINE SYRINGES, MULTIPLE MEDLINE INDUSTRIES, INC.
K061316 05/11/2006 MEDLINE SURGICAL SPONGE SCANNER MEDLINE INDUSTRIES, INC.
K051302 05/19/2005 EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR MEDLINE INDUSTRIES, INC.
K962016 05/23/1996 MEDLINE TITANIUM HEMOCLIPS MEDLINE INDUSTRIES, INC.
K991755 05/24/1999 MEDLINE TENDER WET WOUND DRESSING MEDLINE INDUSTRIES, INC.
K962205 06/07/1996 STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE MEDLINE INDUSTRIES, INC.
K032065 07/03/2003 MEDLINE BAND BAGS AND EQUIPMENT COVERS MEDLINE INDUSTRIES, INC.
K982693 08/03/1998 MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K982694 08/03/1998 MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES MEDLINE INDUSTRIES, INC.
K052168 08/09/2005 MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.
K963362 08/26/1996 MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT MEDLINE INDUSTRIES, INC.
K963360 08/26/1996 MEDLINE BODY HOLDER MEDLINE INDUSTRIES, INC.
K963378 08/27/1996 MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER MEDLINE INDUSTRIES, INC.
K963404 08/29/1996 MEDLINE PELVIC HOLDER MEDLINE INDUSTRIES, INC.
K963569 09/05/1996 WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH MEDLINE INDUSTRIES, INC.
K002968 09/22/2000 MEDLINE STERILIZATION WRAP MEDLINE INDUSTRIES, INC.
K052720 09/29/2005 MEDLINE IODOFORM PACKING STRIPS MEDLINE INDUSTRIES, INC.
K062984 09/29/2006 MEDLINE HYPODERMIC NEEDLES MEDLINE INDUSTRIES, INC.
K062969 09/29/2006 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K003055 10/02/2000 MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MEDLINE INDUSTRIES, INC.
K003091 10/03/2000 MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW MEDLINE INDUSTRIES, INC.
K003353 10/26/2000 MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA MEDLINE INDUSTRIES, INC.
K043017 11/02/2004 PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K003755 12/05/2000 MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES MEDLINE INDUSTRIES, INC.
K965112 12/20/1996 MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS MEDLINE INDUSTRIES, INC.
K053574 12/22/2005 MEDLINE PEDIATRIC WHEELCHAIRS MEDLINE INDUSTRIES, INC.
K043585 12/28/2004 MEDLINE SURGICAL GOWNS MEDLINE INDUSTRIES, INC.
K193666 12/31/2019 Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) û Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff Medline Industries, Inc.
K040838 03/31/2004 MEDLINE STRIDER MINI 4 MEDLINE INDUSTRIES, INC.
K041055 04/23/2004 MEDLINE STRIDER MAXI 4 MEDLINE INDUSTRIES, INC.
K041053 04/23/2004 MEDLINE STRIDER MICRO 3 MEDLINE INDUSTRIES, INC.
K042764 10/05/2004 MEDLINE STRIDER MIDI 4 MEDLINE INDUSTRIES, INC.
K093830 12/14/2009 MEDLINE ANGIOGRAPHIC CONTROL SYRINGE MEDLINE INDUSTRIES, INC.
K170002 01/03/2017 Medline Blood Collection Set Medline Industries, Inc.
K120069 01/09/2012 MEDLINE STOPCOCK AND MANIFOLD MEDLINE INDUSTRIES, INC.
K100302 02/03/2010 MEDLINE PVC URETHRAL CATHETER MEDLINE INDUSTRIES, INC.
K130319 02/08/2013 MEDLINE CANNULATED SCREW MEDLINE INDUSTRIES, INC.
K170415 02/10/2017 Medline Hemo-Force DVT Compression Sleeve Medline Industries, Inc.
K140369 02/14/2014 MEDLINE NEURO SPONGE MEDLINE INDUSTRIES, INC.
K210526 02/23/2021 Medline Cautery Tip Cleaner Medline Industries, Inc.
K090568 03/03/2009 MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN MEDLINE INDUSTRIES, INC.
K160660 03/08/2016 Medline Waste Station Medline Industries, Inc.
K150598 03/09/2015 Blockade Surgical Gown Medline Industries, Inc.
K190643 03/13/2019 Medline Electrocautery Pencil Medline Industries, Inc.
K150731 03/20/2015 Medline Epidural Catheter MEDLINE INDUSTRIES, INC.
K161035 04/13/2016 Medline Singe Patient Use Blood Pressure Cuff MEDLINE INDUSTRIES, INC.
K141127 05/01/2014 MEDLINE ANTI-EMBOLISM STOCKING MEDLINE INDUSTRIES, INC.
K071244 05/03/2007 MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF MEDLINE INDUSTRIES, INC.
K131426 05/17/2013 MEDLINE BIOPSY VALVE MEDLINE INDUSTRIES, INC.
K071423 05/22/2007 MEDLINE LATEX FOLEY CATHETER MEDLINE INDUSTRIES, INC.
K101560 06/04/2010 MEDLINE RETRACTABLE SAFETY SYRINGE MEDLINE INDUSTRIES, INC.
K071552 06/06/2007 PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING MEDLINE INDUSTRIES, INC.
K081594 06/06/2008 MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE MEDLINE INDUSTRIES, INC.
K111577 06/07/2011 MEDLINE VIAL DECANTER MEDLINE INDUSTRIES, INC.
K111807 06/27/2011 MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... MEDLINE INDUSTRIES, INC.
K132314 07/25/2013 MEDLINE ANTI-REFLUX VALVE MEDLINE INDUSTRIES, INC.
K092250 07/28/2009 MEDLINE RED RUBBER URETHRAL CATHETER MEDLINE INDUSTRIES, INC.
K102177 08/02/2010 SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE MEDLINE INDUSTRIES, INC.
K142635 09/17/2014 Medline Silicone Foley Catheter MEDLINE INDUSTRIES, INC.
K213068 09/23/2021 Medline Smoke Evacuation Shroud Medline Industries, Inc.
K122949 09/24/2012 MEDLINE SUCTION COAGULATOR MEDLINE INDUSTRIES, INC.
K192820 10/01/2019 SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc.
K123095 10/02/2012 MEDLINE BLOOD PRESSURE TRANSDUCER MEDLINE INDUSTRIES, INC.
K182812 10/03/2018 Medline Cautery Electrode (SILICONE) Medline Industries, Inc.
K152948 10/06/2015 Medline Anti-Fog Solution Medline Industries, Inc.
K072942 10/17/2007 MEDLINE DISPOSABLE VAGINAL SPECULUM MEDLINE INDUSTRIES, INC.
K173348 10/25/2017 0.9% Sodium Chloride Injection, USP Medline Industries, Inc.
K093349 10/27/2009 MEDLINE CURAD WOUND DRESSINGS MEDLINE INDUSTRIES, INC.
K143147 11/03/2014 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC.
K113353 11/14/2011 GEMINI STERILZATION WRAP MEDLINE INDUSTRIES, INC.
K093726 12/03/2009 MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC.
K113583 12/05/2011 CURAD ANTIBACTERIAL BANDAGE MEDLINE INDUSTRIES, INC.
K103602 12/08/2010 EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM MEDLINE INDUSTRIES, INC.
K103718 12/21/2010 DYNACOR LUBRICATION GEL MEDLINE INDUSTRIES, INC.
K173889 12/21/2017 Medline Cautery Electrode (PTFE) Medline Industries, Inc.
K143693 12/24/2014 MEDLINE SHARPS CONTAINERS MEDLINE INDUSTRIES, INC.
K073718 12/31/2007 MEDLINE GASTROSTOMY TUBE MEDLINE INDUSTRIES, INC.
K220565 02/28/2022 Hudson RCI Triflo II Incentive Deep Breathing Exerciser Medline Industries, Inc.
K160471 02/19/2016 Medline Non-Surgical Isolation Gown- MEDLINE INDUSTRIES, INC.
K180696 03/16/2018 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) Medline Industries, Inc.
K190950 04/11/2019 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 Medline Industries, Inc.
K182172 08/10/2018 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) Medline Industries, Inc.
K172954 09/26/2017 Medline Prevention CoolZone Gown Medline Industries, Inc.
K031933 06/23/2003 MEDLINE REUSABLE SURGICAL GOWNS (100X) MEDLINE INDUSTRIES, INC.
K011240 04/23/2001 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC.
K011515 05/17/2001 MEDLINE GROUNDING PAD MEDLINE INDUSTRIES, INC.
K191378 05/23/2019 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe Medline Industries, Inc.
K212258 07/20/2021 Medline Cardiovascular Procedure Kit Medline Industries, Inc.
K192985 10/25/2019 Medline Glide-On 3G Vinyl Examination Gloves Medline Industries, Inc.
K213481 10/29/2021 Medline General Surgery Tray Medline Industries, Inc.
K150286 02/05/2015 Medline Enteral Feeding Sets MEDLINE INDUSTRIES, INC.
K160642 03/07/2016 Medline ENFit Syringe Medline Industries, Inc.
K151628 06/17/2015 Medline ENFit Connectors MEDLINE INDUSTRIES, INC.
K132767 09/04/2013 MEDLINE SHARPS CONTAINER MEDLINE INDUSTRIES, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact