Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005012805

FEI Number

3005012805

Entity Name

MIDWEST STERILIZATION CORP.

City/State/Country

LAREDO, TX, US

Establishment Address

12010 GENERAL MILTON DR., LAREDO, TX 78045, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

MIDWEST STERILIZATION CORP. (Owner Number: 1928237)

Owner / Operator Contact Address

1204 LENCO AVE., --, Jackson, MO 63755, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LenSx Laser Patient Interface Chest drainage kit Pelvic exam kit Sherpa NX Balanced Medline central venous catheter tray Dress, Surgical Electrosurgical, cutting & coagulation & accessories Medline custom anesthesia kit Regard Medline Catheter Introducer Kit Medline Gauze Sponge Occular Occluder Micro instrument wipe Non-sterile micro instrument wipe Shah aural dressing Ocular occluder O.R. TOWELS; MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS ACCU-SORB STERILE STOCKINETTES; MEDLINE STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE MEDLINE ASEP PLUS SURGICAL DRAPES; MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES; GORE-TEX NON-STERILE SURGICAL GOWNS INFINITI Vision System, Accessories, and FMS Paks ASHERMAN CHEST SEAL Lyka Port CURETTE Regard Medline laparoscopy kit Pleur-evac; Pleur-evac Chest Drainage System Cricothyrotomy kit okg Medline stopcock and manifold Medline suture boot Medline surgical tray Cardioblate® Surgical Ablation Pen Cardioblate® LP Device Cardioblate® XL Pen Cardioblate® BP2 Device General purpose dental tray Medline anesthesia mask Cardioblate® Surgical Ablation Pen Cardioblate® XL Pen Medline orthopedic tray Regard CATHETER, RETENTION TYPE, BALLOON Universal Sterilization Tray 10MM Universal Sterilization Tray 7MM Medline sterile instruments Medline eye tray Regard Medline surgical leggings 99671 Chinook Chest Drain Valve Cardiopulmonary resuscitation aid kit Dynacor Poole Suction Tip; sterile physiological saline sterile water; Medline suction catheters; Yankauer suctioning SP-4000 Otomed Suction Tubing Dynacor closed BA; Low profile drainage bags; Penrose drains sterile latex Disposable Canister Liner Reusable Suction Canister PE SAHARA DRY SUCT/DRY SEAL LF 6/CS PE PNEUMONECTOMY LF 6/CS PE ADULT-PED WET LF 6/C PE MINI SAHARA 6/BX LATEX FREE PE ADULT-PED DRY/ WET LF 6/CS PE ADULT-PED WET LF 6/CS Medline nerve block tray / kit Medline PVC Urethal Catheter Medline high pressure tubing Medline bypass kit Regard MEDLINE STERILE 100% SILICONE FOLEY CATHETER; MEDLINE STERILE CLOSED SYSTEM; DYNACOR STERILE CARELON SILICON CATHETER; DYNACOR URETHRAL CATHETER TRAY; MEDLINE UROLOGICAL KIT W/STERILE, WATER FILL Scissors, Orthopedic, Surgical Vacuum powered body fluid collection Kit Medline biopsy tray Drapes, Patient, ophthalmic TRAP, STERILE SPECIMEN APPLICATOR, ABSORBENT TIPPED, STERILE Medline spinal epidural anesthesia kit Kidney perfusion kit Cardioblate® Gemini® -s Surgical Ablation Device Medline plastic surgery kit Regard Tray, surgical, needle E-Z lubricating gel; Dynacor Lubricant Gel MEDLINE ASEP PLUS SURGICAL DRAPES; MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES; GORE-TEX NON-STERILE O.R. TOWELS; X Graduated Pitcher; Medicine Cup Medline liquid medication dispenser GRADUATED CONTAINER 500 ML, LIDDED Transducer, blood-pressure, extravascular Cardioblate® BP2 Device Cardioblate® LP Device Cardioblate® Gemini® -S Surgical Ablation Device Medline tracheostomy cleaning tray Medline maternity kit E-Z lubricating gel; Dynacor lubricant gel PTICS PROBES, SCISSORS, FORCEPS, GRASPERS AND NEEDLE HOLDERS Medline Electrosurgical Instruments; ENDOSWAB LAPAROSCOPIC SURGERY INSTRUMENTS; MARTIN COLD LIGHT FOUNTAIN LAPAROSCOPY O Medline cesarean section kit Arterial blood sampling kit clamp Medline limb cover TRAY, BLOOD COLLECTION HOLDER, URETERAL CATHETER Berman airways; Dynacor airways Medline DVT Therapy Compression ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Medline hysterectomy kit Regard Medline tracheotomy care kit Medline breathing circuit Humidifier nebulizer kit I.V. START KIT WITH OPSITE & CHLORAPREP I.V. START KIT WITH TEGADERM AND CHLORASCRUB I.V. START KIT - CHILD NOVAPLUS I.V. START KIT I.V. START KIT WITH TEGARDERM AND CHLORAPREP Medline IV start kit I.V. START KIT I.V. START I.V. START KIT W/BIOCLUSIVE DRESSING PEDIATRIC I.V. START KIT I.V. START KIT WITH TEGADERM DRESSING I.V. START KIT W/LSL DRESSING AND CHLORASCRUB I.V. START KIT W/BIOCLUSIVE DRESSING AND CHLORAPREP STERILE Medline ENT surgical tray / kit Regard Medline insufflation tubing Trocar kit Medline arthrogram tray Medline sterile OR label/tag BASIN, EMESIS Aloetouch exam glove Device, Percutaneous, Biopsy Endoscopic guidewire, gastroenterology-urology Wire, guide, catheter Medline anesthesia kit BASIC BIOPSY PACK BIOPSY TRAY Medline biopsy tray Medline Biopsy Packs NEEDLE, SUTURING, DISPOSABLE UNITY Vitreoretinal Cataract System,UNITY Cataract System Accessories and FMS Packs Mediguard nitrile glove Alcon Endoilluminators PREMIUM DRY SKIN PREP TRAY PREMIUM WET SKIN PREP TRAY PATIENT PREP TRAY Medline skin prep tray / kit DRY SKIN PREP KIT Medline surgical razor bsp Medline airway connector FORCEPS Medline breathing circuit bacterial filter Medline applicator / vaginal/cervical scraper FOLEY CATHETERIZATION TRAY WITHOUT CATHETER Medline catheter care kit / tray Medline irrigation tray Medline neurological tray Regard PE SAHARA DRY SUC/SEAL CONT REINF LF 6 Medline stapler Laser Probes Dialysis administration kit INSTRUMENT, SURGICAL, DISPOSABLE Intravenous extension tubing set ACCESSORIES, CATHETER Mixer, Cement, For Clinical Use Dynacor oxygen connecting tube; Medline pressure tubing Foley catheter kit (excludes HIV testing) Medline aspiration tray / kit CONSTELLATION Vision System and Accessories Laceration tray Guide, Needle, Surgical Stopcock, i.V. Set Sensicare exam glove Medline breath bag EPIDURAL NEEDLE Sampler, amniotic fluid (amniocentesis tray) Medline cardiac catheterization kit Regard Tissue Processing Kit Forceps, Biopsy, Gynecological Medline epidural anesthesia kit Holder, Needle, Gastroenterologic Tracheostomy and nasal suctioning kit Hemostat Aloetouch Nitrile Glove Medline head strap Phlebotomy blood collection kit Electrosurgical, cutting & coagulation and accessories Legion Vision System, Accessories, and FMS Packs Electrosurgical, cutting & coagulation & accessories PE DRY/WET CONT REINFUSION LF 6/CS STERILE MIDSTREAM SPECIMEN, CASTILE SOAP MID-STREAM URINE SPECIMEN KIT - 120 ML STERILE MIDSTREAM URINE SPECIMEN KIT Bitingual instruction; Dynacor containers; Midstream collection kits; Medline Specimen containers STERILE SPECIMEN CUP WITH TAB TOP, OR PACK STERILE SPECIMEN CONTAINER WITH SCREW TOP SCREW TOP SPECIMEN CONTAINER, 4 OZ STERILE MIDSTREAM SPECIMEN, BZK Cotton, Roll CLAMP, CIRCUMCISION Affinity Pixie Arterial Filter with Balance Biosurface Affinity® Pediatric Arterial Blood Filter Curad compression hosiery First aid kit without drug Imager II Urology Torque Catheters Medline obstetrical kit Endoscope introducer kit Breast biopsy / localization tray Medline rectal tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-12-23
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2024-12-23
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2024-12-23
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2021-11-15
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2021-11-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-09-08
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2012-11-08
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-11-15
OGD	Custom Anesthesia Tray	Anesthesiology	Class 2	868.5120	2012-09-12
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2012-11-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-11-08
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2012-11-09
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2025-01-28
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2025-01-28
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2025-01-28
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2025-01-28
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2024-12-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-07-15
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-11-15
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2012-09-12
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2024-12-23
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2021-11-16
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2022-03-28
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-11-08
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2012-11-09
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-11-09
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2025-05-28
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2021-11-16
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2012-11-08
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2025-05-28
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2012-09-12
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2021-11-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-09-21
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2012-09-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2012-11-08
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-11-08
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-09-21
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-11-04
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2012-11-08
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2012-11-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-08
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2012-09-12
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-11-09
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2024-12-16
OJR	Vacuum Powered Body Fluid Collection Kit	General, Plastic Surgery	Class 2	878.4780	2021-11-15
OFG	Ct Biopsy Tray	Cardiovascular	Class 2	870.4075	2012-11-08
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2025-01-22
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2021-11-15
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-11-15
OFT	Spinal Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2012-11-08
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2025-05-28
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2012-09-12
FSH	Tray, Surgical, Needle	General, Plastic Surgery	Class 1	878.4800	2021-11-15
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2012-11-08
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2012-11-08
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2012-09-21
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2022-12-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-28
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2025-05-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-28
OGV	Tracheostomy Cleaning Tray	Anesthesiology	Class 2	868.5800	2012-11-08
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2012-09-12
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2012-11-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-08
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2012-09-12
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2021-11-16
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-12-16
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2012-11-08
GJE	Tray, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-11-16
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2021-11-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2012-11-09
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2012-11-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-11-15
OJF	Hysterectomy Kit	Obstetrics/Gynecology	Class 2	884.4530	2012-09-12
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2012-11-08
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2012-11-08
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2021-11-16
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2012-09-21
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2012-09-12
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2012-11-08
OKX	Trocar Kit	Obstetrics/Gynecology	Class 2	884.1720	2021-11-16
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2012-11-09
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2012-11-08
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2021-11-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-11-08
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2024-12-16
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-12-09
OFQ	Anesthesia Kit	Anesthesiology	Class 2	868.5120	2012-11-08
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2012-11-09
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2012-11-08
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-11-15
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-07-11
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2024-07-11
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-07-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-11-08
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2024-12-23
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2012-09-21
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-03-28
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2012-11-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-11-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-11-08
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2012-11-08
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2012-09-21
EYN	Tray, Irrigation, Sterile	Gastroenterology, Urology	Class 2	876.5980	2012-11-09
OJG	Neurological Tray	Neurology	Class 1	882.4525	2012-09-12
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2022-12-09
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2012-11-08
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2024-12-23
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2021-11-15
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-11-15
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2021-11-15
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2021-11-15
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2024-12-16
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-11-08
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2021-11-15
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2012-11-09
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-08-30
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-08-30
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2021-11-15
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-16
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2021-11-15
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2012-11-08
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2012-11-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2024-12-23
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2021-11-15
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2012-09-12
PFU	Tissue Processing Kit	Unknown	Class N	N/A	2021-11-16
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2012-09-21
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2012-11-08
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2024-12-16
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2021-11-16
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2024-12-16
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-11-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2012-11-08
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2012-11-09
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2021-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-09
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2022-12-09
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-09-21
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-12-16
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2021-11-15
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2026-01-20
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2012-11-09
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2021-11-15
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-07-22
OKV	Obstetrical Kit	Obstetrics/Gynecology	Class 2	884.4520	2012-11-08
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2021-11-15
PXP	Breast Biopsy / Localization Tray	General, Plastic Surgery	Class 1	878.4800	2021-11-16
OOW	Applicator For Rectal Suppository	Gastroenterology, Urology	Class 1	876.4730	2012-11-09

Official Correspondent

KAREN ELDRIDGE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MIDWEST STERILIZATION CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Z-2109-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005012805. Last updated year: 2026. Please use registration number 3005012805 when referencing this establishment in official correspondence.