Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015173212

FEI Number

3015173212

Entity Name

Medline Industries, LP - Mexicali (MXC)

City/State/Country

Mexicali Baja California, MX

Establishment Address

Calle Circuito del Desierto # 71, Parque Industrial del Desierto, Mexicali Baja California 21383, MX

Establishment Type(s)

Repack or Relabel Medical Device,Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDLINE / CDS PLASTIC SURGERY KIT AND ACCESSORIES Intellis Spinal Cord Stimulation Systems Fluid Administration Set Medline surgical kits/trays and CDS modules MEDLINE General surgery tray (kit) Medline / Eclipse / Aurora / Sirus surgical packs Convenience Trays & Kits CSTM Medline Proxima DYNACOR CONTAINERS Medline/Centurion Sterile Bowl, Sterile Pitcher Medline Pathology Container Centurion Pathology Container Medline Midstream Collection Kit Medline Specimen Container NAMIC Vascular Adaptors and Caps Medline/Konig Cardiovascular Surgical Instruments NAMIC Bottle/SOSA Spike Clip Medline arterial needle Restraint, protective Medline / CDS catheter care tray (kit) Medline Foley Catheterization Tray Medline Urethral Catheterization Tray Medline/Konig Forceps Forceps Medline Laceration Tray Alcohol Towelettes Alcohol Prep Pad High Pressure Tubing with Rotator Medline General Purpose Dental Tray Medline Endo Kit Medline Endoscope Introducer Kit Medline Access Care Kit Medline Dialysis Tray Centurion Dialysis Tray NAMIC MLL-RA Adaptor NAMIC Manifold Clamp NAMIC Standard Peripheral Vascular Angiographic Kit NAMIC Angiographic Pressure Monitoring Manifolds NAMIC Angiographic Manifold NAMIC Standard Angiographic Kit NAMIC Stopcock Medline / CDS nuerological tray (kit) Medline Breathing Circuit Medline Adult Expandable Anesthesia Circuit NAMIC Fluid Delivery Set NAMIC Protection Station NAMIC Sosa Spike NAMIC Fluid Administration Set NAMIC Closed Fluid Systems NAMIC Filling Station NAMIC Filling Station Plus NAMIC Contrast Removal Valve NAMIC Protection Station Plus Manifold, Stopcock, and Adapter MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS Medline M/M Adapter NAMIC 3-Way Stopcock NAMIC Adaptors/Connectors Push Style Y-Adapter NAMIC Stopcock Insufflation Tubing Laparoscopic Insufflation Tubing Medline / CDS epidural anesthesia kit (tray) Medline Centurion Scissors Medline O/R Scissors Medline/Konig Scissors, General & Surgical Suture Anchor Medline / CDS laparoscopy kit Medline / CDS central venous catheter tray (kit) Wire, guide, catheter Medline Single Use Instrument Tray Kit Biopsy Needle Jamshidi Needle ELECTRODE, PACEMAKER, TEMPORARY ICONIX SELF-PUNCHING Medline Surgical Scrub Brush SCRUB-IN Medline Peripheral Nerve Block Needle Medline Biohazard Specimen Bag Medline Pathology Container Medline Specimen Container Medline Medicine Cup Medline Triangular Graduate Container Diagnostic Guidewire Medline Epidural / Spinal Needles MEDLINE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) - BSP Medline Pelvic Exam Kit Medline Decontamination Kit Medline Body Fluid Clean Up Kit MEDLINE Syringe, piston - FMF Medline Sterile Luer Lock Syringes Medline / Konig Guide, Needle, Surgical Angiography Introducer Needle MEDLINE Eye tray NAMIC Insertion Tool Angio-SAC Collection System NAMIC Angiographic Bags Pkg., Assy., Peek MIRROR, ENT Medline/Konig Uterine Sound Medline / CDS biopsy tray or kit Medline Lumbar Puncture Tray 321236-Sterile Biospy CSTM Sterile OR Towel Sterile X-Ray Detectable OR Towels Fluid Administration Set Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad Medline Blood And Urine Collection Kit (Excludes Hiv Testing) BULKEE II CURAD BULKEE LITE Caring abdominal pads CURAD Naturals Medline Abdominal Pad Medline ACCU-SORB Medline patient personal hygiene kit Peek Zip Twinloop Flex Pad, alcohol, device disinfectant SURGICAL LEGGINGS Medline Coveralls AngelStat Medline Medline Chest Drainage Kit PleuraGuide Disposable Chest Tube Kit / Tray Medline Wound Dressing Kit Diagnostic Guidewire NAMIC Femoral Introducer Kit Medline / CDS cesarean section kit (tray) Secureview SorbaView 2000 Medline SeeIV SorbaView SorbaView SHIELD HubGuard Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Disposable Pressure Transducer Medline Intravascular Administration Set Medline / Konig Razor, Surgical Carefusion Clipper Blade Medline Clipper Blade Medline Surgical Clipper Medline Razor Sweep Bio Prep Kit Medline Needle Counter High Pressure Tubing with Rotator High Pressure Contrast Injection Tubing ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) ICONIX SELF-PUNCHING Medline Wound Drain Penrose Drain Pkg., Wedge Hs Suture Anchor 11, 6.5mm Centurion Forceps Medline / Konig Forceps, General & Plastic Surgery Medline Toomey Irrigation Syringe Medline Irrigation Tray Medline Ear Syringe Medline Irrigation Syringe EntraFlo Medline Irrigation Bottle Medline Suture Boot Medline Double Mesh Strainer Medline Towel Clamps/Sponge Forceps Medline Surgical Instrument Centurion Cuticle and Tissue Nippers Medline/Konig Hook, Surgical, General & Plastic Surgery Syringe, piston MEDLINE LABEL OR TAG, STERILE NAMIC Contrast Management System NAMIC Contrast Controller NAMIC Squeeze Contrast Controller Diagnostic Guidewire MEDLINE BIOPSY KIT/TRAY CENTURION BIOPSY KIT/TRAY MEDLINE / CENTURION BREAST IMAGING TRAY Cath Kit 170019-Convenience Trays & Kits CSTM Medline General Surgery Tray Medline Basin Tray Eclipse Surgical Pack Medline surgical kits/trays and CDS modules Aurora Surgical Pack Sirus Surgical Pack NAMIC Pediatric Pressure Monitoring Lines NAMIC Adaptor NAMIC Pressure Monitoring Lines One-Way Stopcock Medline Tracheostomy And Nasal Suctioning Kit Centurion Tracheostomy And Nasal Suctioning Kit Diagnostic Guidewire MEDLINE TRAY, SURGICAL - LRP Medline/Konig Surgical Tray 137075-Surgical SetUp CSTM Medline Count Sheet Holder Medline / CDS skin prep tray (kit) 946240-Skin Prep CSTM Symphony Accessory Pack Wet Skin Prep Tray with Povidone Iodine Scrub and Paint Solution Dry Skin Surgical Scrub Tray with Gauze, Premium Dry Surgical Scrub Tray Pkg, Four Spike Irrigator Set Medline Nylex Covered Foam Medline / CDS obstetrical kit Medline Pelvic Exam Kit Medline / CDS cardiac catheterization kit FORCEPS, TUBE INTRODUCTION HANDLE, SCALPEL BERMAN AIRWAYS MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE DYNACOR AIRWAYS "Salt Airway S.A.L.T." VARIOUS SIZES DYNACOR AIRWAYS Medline Hard Guedel Airway Medline / Konig Scissors, Orthopedic, Surgical Medline / CDS catheter introducer kit Medline / CDS maternity kit MEDLINE Labor and Delivery Kit - MLS Angiography Introducer Needle Medline/Konig Gynecological Biopsy Forceps Medline ADAPTOR, DRESSING Suture SecurePortIV Core Disposable Dual Medline Blood Pressure Transducer Orthopedic Kits General and Plastic Surgery Kits Foley Catheter Insertion Tray Cardiovascular Kits Clinical Chemistry and Clinical Toxicology Kits Anesthesiology Kits Obstetrical and Gynecological Kits General Hospital and Personal Use Kits Dental Kits Medline General Surgery Tray Ear, Nose, and Throat Kits Physical Medicine Kits Gastroenterology-Urology Kits Radiology Kits Ophthalmic Kits Neurological Kits Medline Disposable Skin Stapler Manipler Skin Stapler Skin Staple Removers Medline Catheter Leg Strap Medline Urethral Catheter Holder Medline Foley Catheter Securement Device Diagnostic Guidewire Centurion / Medline Central Line Pack CLAMP, CIRCUMCISION Sensicare PI Ortho Sensicare PI Green with Aloe Medline Dialysis Tray Medline Access Care Kit Medline Total 1-Layer Silicone Catheter Tray with Urine Meter Medline Endo Tray Triumph Surgical Gloves Triumph Micro Surgical Gloves Triumph LT Surgical Gloves Medline Urinal Microtek Medline/Konig Electrosurgical, Cutting & Coagulation & Accessories Medline Electrosurgical Pencil / Pad / Accessory CURAD Medline Nitrile Exam Gloves FitGuard Touch Powder-Free Nitrile Exam Gloves Core Disposable Single Blood specimen collection device Catheter, intravascular, therapeutic, short-term less than 30 days Medline Critical Response Medline / CDS spinal epidural anesthesia kit (tray) Medline UNITE Burrs Medline Navilyst Medical Convenience Kit Medline Angiography/Angioplasty Kit Medline Catheter Plug and Drain Tube Protector Centurion Catheterization Kit Medline Catheterization Kit Medline Suture Removal Tray 140928-Suture Removal Kit CSTM Medline Suture Kit COVERED YANKAUER MEDLINE EVACUATOR, ORAL CAVITY - EHZ Manifold Medline Cardiovascular Procedure Kit Medline / CDS arthrogram tray SilverTouch Silicone Foley Catheter MEDLINE CATHETER, UROLOGICAL - KOD NAMIC Stopcock NAMIC Port Protector Introducer, catheter Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Medline Surgical Stapler Medline Fluid Administration Set Sonopet iQ Irrigation Suction Cassette Contrast Management System Medline Central Venous Catheter Dressing Change Kit Medline Urinary Drain Bag Medline Drain Bag Strap Medline Leg Bag Lingeman Medline 5-in-1 connector Medline Connecting Tubing MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY DYNACOR SUCTION CONNECTING TUBING Medline Cautery Tip Cleaner Electrosurgical Cords Medline / CDS custom anesthesia kit Medline / CDS cardiac catheterization kit Medline / Konig Catheter and Tip, Suction SUCTION CATHETERS DYNACOR - POOLE SUCTION TIP Ortho YANKAUER SUCTIONING INSTRUMENTS MEDLINE CATHETER AND TIP, SUCTION - JOL STERILE PHYSIOLOGICAL SALINE STERILE WATER Triumph LT Surgical Gloves Stopcock Compass Universal High-Pressure Medication Syringe Medication Syringe Medline / CDS anesthesia kit or crash cart Stopcock Medline M/M Adapter MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS - DTL Medline stopcock / manifold Pkg, Dual Irrigation Adapter For Saleable Product ICONIX 2 NEEDLES Syringe, Piston Medline Disposable Tourniquet Medline Radial Compression Band MEDLINE SYSTEM, IRRIGATION, UROLOGICAL - LGH Y-TYPE TUR/BLADDER IRRIGATION SET Centurion Arterial Blood Sampling Kit Medline Arterial Blood Sampling Kit Angiography Introducer Needle Medline Biopsy Valve Syringe, piston Angiographic Syringe Surgical Drape NAMIC Diagnostic Guidewire Tubing, fluid delivery Medline / CDS ear, nose, and throat surgical tray (kit) Medline Radiofrequency Ablation Needle CURAD Naturals Medline Set, administration, intravascular Medline / CDS gynecological laparoscopic kit (tray) Contrast Management System DuoCare Pint-Sized Medline Medline Scraper, Vaginal/Cervical Applicator, Vaginal/Cervical MEDLINE APPLICATOR, VAGINAL - HGD Medline / CDS CT biopsy tray (kit) Medline / CDS hysterectomy kit (tray) Speculum, vaginal, nonmetal MedFix EZ Sorbaview Polar Dressing CURAD SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc Knotless Anchor Medline / Konig Device, Percutaneous, Biopsy Medline Biospy Tray Medline Dressing Change Tray 145666-Dressing Change CSTM Medline Medline Basin Kit Centurion Basin Kit Medline Cotton-Tipped Applicators Medline CURAD Meijer Medline Clearpro Closed Suction Catheter Medline Tracheobronchial Suction Catheter Medline Open Suction Catheter System, irrigation, urological Medline disposable laryngoscope blade Prevention Surgical Gowns ICONIX 2 Tape INSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC NasoPharyngeal Airways Medline / CDS aspiration tray, kit Summit / Infinity OR towels Medline OR Towels Ultrasorbs Dry Sheets ORLocate Towels Medline Cotton Balls Medline / CDS ENT surgical tray, kit Probes Medline/Konig Speculum, ENT Medline Nasal Speculum

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-09-15
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-01-17
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2023-01-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-24
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2019-02-28
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-01-09
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2025-03-24
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-02-14
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2025-03-26
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2010-08-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-10-05
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2015-12-09
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2023-10-25
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-04-15
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2015-12-16
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2015-01-19
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
OJG	Neurological Tray	Neurology	Class 1	882.4525	2010-08-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-11-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-11-20
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-02-27
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-03-24
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2011-10-18
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2008-07-09
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2010-11-10
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-10-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2010-08-09
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2008-07-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-26
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2015-12-16
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-02-26
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-03-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2005-10-05
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-03-25
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2009-06-19
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	1977-12-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-03-26
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2011-07-25
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-13
MAC	Decontamination Kit	General, Plastic Surgery	Class 1	878.4014	2015-12-09
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2015-12-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-02
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-03-31
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2010-08-09
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-03-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-08-01
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2015-04-27
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	1997-06-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2010-09-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-24
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2016-08-22
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-20
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2015-12-09
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2002-12-13
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2006-02-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-03-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	1992-01-10
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2015-12-24
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2008-07-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-03-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-03-24
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2008-07-09
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2018-04-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-03-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-06-05
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-11-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-10
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2024-12-10
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-08-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2023-06-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1992-01-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-03-31
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2005-02-01
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1987-01-05
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-04-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-03-24
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2011-09-03
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2019-11-04
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-03-26
PXP	Breast Biopsy / Localization Tray	General, Plastic Surgery	Class 1	878.4800	2021-03-17
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2010-08-09
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2006-08-08
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2019-11-12
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-03-24
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2021-03-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-24
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	1991-12-30
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2010-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-10
OKV	Obstetrical Kit	Obstetrics/Gynecology	Class 2	884.4520	2011-09-15
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2023-03-30
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-03-31
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-02-01
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2015-03-31
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2008-07-15
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-07-09
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-03-24
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2015-04-27
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2025-03-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
NZP	Sealant, Microbial	General, Plastic Surgery	Class 2	878.4370	2026-04-01
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-12-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-11-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-11-19
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2013-06-11
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2023-10-24
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2017-12-01
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	1991-12-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-03-26
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	1987-03-30
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2023-06-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-25
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-03-25
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2015-01-20
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2021-09-21
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-10-27
FNP	Urinal	General Hospital	Class 1	880.6730	1991-12-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-05-16
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-02-24
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-12-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-03-30
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2020-07-28
OFT	Spinal Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2008-07-09
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2023-08-01
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2008-07-09
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-30
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-02-01
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2015-12-16
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2007-01-10
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2008-07-15
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2010-08-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-12-16
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-03-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-02-01
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2011-09-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-14
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-12-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-24
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2015-12-16
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2005-12-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2005-02-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-05-12
OGD	Custom Anesthesia Tray	Anesthesiology	Class 2	868.5120	2008-07-09
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2005-02-01
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2010-06-14
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-03-24
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-06-06
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2023-06-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-11-22
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2015-04-08
OFQ	Anesthesia Kit	Anesthesiology	Class 2	868.5120	2008-07-09
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2013-11-01
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-04-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-11-22
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-02-01
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-08-25
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2021-03-08
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-03-24
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2014-02-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-03-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-03-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-03-02
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-03-24
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-03-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-25
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2023-03-30
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2010-08-10
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2025-03-24
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-03-24
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2011-09-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-04-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-03-30
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2011-09-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2018-02-16
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	1982-09-17
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2011-09-23
OFG	Ct Biopsy Tray	Cardiovascular	Class 2	870.4075	2010-08-09
OJF	Hysterectomy Kit	Obstetrics/Gynecology	Class 2	884.4530	2011-09-15
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2026-06-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-02-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2015-03-31
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-09
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1991-12-30
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2016-02-16
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2009-11-19
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2005-02-01
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-03-26
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-11-24
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-02-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-10
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2022-11-10
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2024-06-24
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2010-08-09
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1996-09-24
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-08-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-10
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2015-04-08

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015173212. Last updated year: 2026. Please use registration number 3015173212 when referencing this establishment in official correspondence.