Data / Medical devices / Mexico / Productos Medline S.A. De C.V.
Productos Medline S.A. De C.V.: FDA-registered device maker in NUEVO LAREDO Tamaulipas, Mexico, 25 510(k) clearances
Productos Medline S.A. De C.V. is registered with the FDA (registration 3004122598) in NUEVO LAREDO Tamaulipas, Mexico. It lists 110 device types. The FDA files 25 510(k) clearances under its listings, the newest dated November 18, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004122598
- Address
- BLVD. World Trade Center No.106 Parque Industrial Oradel, NUEVO LAREDO Tamaulipas, Mexico, 88285
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 29, 1977
- Registered through
- 2026
- Brand names listed
- 137075-Surgical SetUp CSTM, 140928-Suture Removal Kit CSTM, 145666-Dressing Change CSTM, 147572-Sterile Circumcision Tray CSTM, 321236-Sterile Biospy CSTM, 946240-Skin Prep CSTM, ACCU-SORB, AKTORmed and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Catheter | KGZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | 1 | Manufacturer | accessdata.fda.gov |
| Anesthesia Conduction Kit | CAZ | 2 | Manufacturer | accessdata.fda.gov |
| Angiography/Angioplasty Kit | OEQ | 2 | Manufacturer | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Manufacturer | accessdata.fda.gov |
| Bedpan | FOB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Manufacturer | accessdata.fda.gov |
| Body Fluid Clean Up Kit | OKG | 2 | Manufacturer | accessdata.fda.gov |
| Burn Kit Without Drug | OJJ | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Cardiac Catheterization Kit | OES | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Catheter Care Tray | OHR | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Central Venous Catheter Tray | OFF | 2 | Manufacturer | accessdata.fda.gov |
| Cesarean Section Tray | OHM | 2 | Manufacturer | accessdata.fda.gov |
| Chemotherapy Spill Clean-Up Kit | PWT | 1 | Manufacturer | accessdata.fda.gov |
| Chest Drainage Kit | PAD | 2 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Circumcision Tray | OHG | 2 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Manufacturer | accessdata.fda.gov |
| Ct Biopsy Tray | OFG | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dialysis Administration Kit | PEV | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing Change Tray | OXQ | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ear, Nose, And Throat Surgical Tray | OGR | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Introducer Kit | NWU | 2 | Manufacturer | accessdata.fda.gov |
| Epidural Anesthesia Kit | OGE | 2 | Manufacturer | accessdata.fda.gov |
| Eye Tray | OJK | 2 | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | 2 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Dental Tray | OFX | 1 | Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gynecological Laparoscopic Kit | OHD | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Humidifier Nebulizer Kit | OGG | 2 | Manufacturer | accessdata.fda.gov |
| Hysterectomy Kit | OJF | 2 | Manufacturer | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Label Or Tag, Sterile | LYV | 1 | Repackager or relabeler | accessdata.fda.gov |
| Labor And Delivery Kit | MLS | 2 | Manufacturer | accessdata.fda.gov |
| Laceration Tray | PKD | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscopy Kit | FDE | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Neurological Tray | OJG | 1 | Manufacturer | accessdata.fda.gov |
| Obstetrical Kit | OKV | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer | accessdata.fda.gov |
| Patient Personal Hygiene Kit | NSB | 1 | Manufacturer | accessdata.fda.gov |
| Pelvic Exam Kit | MLT | 2 | Manufacturer | accessdata.fda.gov |
| Personal Protection Kit | PXC | 1 | Manufacturer | accessdata.fda.gov |
| Plastic Surgery And Accessories Kit | FTN | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Manufacturer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Skin Prep Tray | OJU | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spinal Epidural Anesthesia Kit | OFT | 2 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Suture Removal Kit | MCZ | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tracheobronchial Suction Catheter Kit | OFR | 1 | Manufacturer | accessdata.fda.gov |
| Tracheotomy Care Kit | NXA | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Trap, Sterile Specimen | BYZ | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Irrigation, Sterile | EYN | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Ent | MMO | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Urinal | FNP | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing Kit | MCY | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| November 18, 2020 | 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 | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| March 6, 2020 | K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 28, 2020 | K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifeciences, LLC | accessdata.fda.gov |
| December 20, 2016 | K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) | KGO | Substantially Equivalent | Hartalega Sdb. Bhd. | accessdata.fda.gov |
| November 3, 2016 | K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter | FOZ | Substantially Equivalent | Medsource International, LLC | accessdata.fda.gov |
| November 2, 2015 | K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| January 31, 2013 | K113353 | GEMINI STERILZATION WRAP | FRG | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| October 26, 2012 | K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING | FRO | Substantially Equivalent | Medtrade Products , Ltd. | accessdata.fda.gov |
| May 15, 2009 | K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | KGO | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| October 9, 2003 | K032196 | NBD DISPOSABLE RF CANNULAE | GXI | Substantially Equivalent | New Business Development, LLC | accessdata.fda.gov |
| September 22, 2003 | K032065 | MEDLINE BAND BAGS AND EQUIPMENT COVERS | MMP | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| August 1, 2002 | K013093 | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM | CAH | Substantially Equivalent | Pall Medical | accessdata.fda.gov |
| January 23, 2002 | K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| December 10, 1998 | K983187 | MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE | KNW | Substantially Equivalent | Medsol Corp. | accessdata.fda.gov |
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 26, 1996 | K962205 | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| March 10, 1995 | K946283 | COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM | JSM | Substantially Equivalent | Copan Diagnostics, Inc. | accessdata.fda.gov |
| February 22, 1994 | K932654 | ELECTROSURGIAL INSTRUMENTS | GEI | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| September 16, 1993 | K925591 | MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST | BZR | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 26, 1993 | K925217 | MERIDIAN MEDICAL SYSTEMS BREATHING FILTER | CAH | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 26, 1991 | K903493 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | IZI | Substantially Equivalent | North American Instrument Corp. | accessdata.fda.gov |
| May 30, 1985 | K852140 | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) | FPA | Substantially Equivalent | North American Instrument Corp. | accessdata.fda.gov |
| October 18, 1984 | K843726 | NAMIC ADB ANGIOGRAPHIC DUMP BAG | DQO | Substantially Equivalent | North American Instrument Corp. | accessdata.fda.gov |
| January 23, 1979 | K782095 | STOPCOCKS, MANIFOLDS | DTL | Substantially Equivalent | Namic | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- All makers of Dressing, Wound, Drug
- All makers of Cover, Barrier, Protective
- All makers of Dress, Surgical
- All makers of Chemotherapy Spill Clean-Up Kit
- All makers of Tray, Irrigation, Sterile
Updated November 18, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.