FDA Device Registration & Listing · Hazelwood, MO, US · Registration 1921846
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2010-07-02 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-07-27 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2010-11-11 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2013-05-03 |
| FOD | Device, Occlusion, Umbilical | General Hospital | Class 1 | 880.5950 | 2024-06-10 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 1999-08-04 |
| FOK | Pad, Neonatal Eye | General Hospital | Class 1 | 880.5270 | 2006-05-26 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2022-05-25 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2022-05-25 |
| ILG | Stocking, Elastic | Physical Medicine | Class 1 | 890.3475 | 2003-07-01 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2005-04-13 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-31 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2009-05-15 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| FCE | Enema Kit | Gastroenterology, Urology | Class 1 | 876.5210 | 2002-02-23 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2021-09-21 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2019-06-17 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-03 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2003-08-05 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | Class U | N/A | 2008-01-10 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2001-08-22 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2011-07-08 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| PTM | Syringe, Balloon Inflation, Exempt | Cardiovascular | Class 2 | 870.1650 | 2020-08-27 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| HED | Douche Apparatus, Vaginal, Therapeutic | Obstetrics/Gynecology | Class 1 | 884.5900 | 2002-02-23 |
| KYR | Bag, Ice | General Hospital | Class 1 | 880.6050 | 2006-04-11 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2019-12-05 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2009-09-23 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-08-14 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2007-12-17 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2018-07-27 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-05-22 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-15 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2004-06-03 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 1999-10-14 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2016-05-23 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2016-05-23 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2008-01-10 |
| PPB | Foley Catheter Kit (Excludes Hiv Testing) | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-04-20 |
| FSD | Binder, Abdominal | General Hospital | Class 1 | 880.5160 | 1996-12-16 |
| EXR | Urinometer, Mechanical | Gastroenterology, Urology | Class 2 | 876.1800 | 1993-01-14 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2023-02-01 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2006-02-13 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| KXO | Monitor, Pressure, Intrauterine | Obstetrics/Gynecology | Class 2 | 884.2700 | 2006-09-22 |
| SDV | Clinical Electronic Thermometer | General Hospital | Class 2 | 880.2910 | 2026-02-20 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2010-05-03 |
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2016-04-14 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2007-12-17 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2008-01-17 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-08-14 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2021-08-16 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | Obstetrics/Gynecology | Class 2 | 884.2675 | 2008-01-11 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2023-01-24 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-06-17 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-10-06 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-16 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2008-01-10 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2011-04-19 |
| FRQ | Tube, Levine | Gastroenterology, Urology | Class 2 | 876.5980 | 2014-03-24 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-06-17 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2011-06-17 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2011-07-11 |
| HCC | Device, Biofeedback | Neurology | Class 2 | 882.5050 | 2024-06-21 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2012-05-07 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Gastroenterology, Urology | Class 2 | 876.1800 | 2002-02-23 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2023-01-18 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2011-11-10 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2023-12-28 |
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | Class 1 | 878.4730 | 2004-04-07 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2013-03-26 |
| KPE | Container, I.V. | General Hospital | Class 2 | 880.5025 | 2008-01-11 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2010-10-25 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2009-07-08 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1999-02-12 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | General, Plastic Surgery | Class 2 | 878.4040 | 2019-04-29 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-04-29 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2009-07-02 |
| HCC | Device, Biofeedback | Neurology | Class 2 | 882.5050 | 2023-11-29 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 1995-08-03 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 1990-01-03 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2023-08-17 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-05 |
| ERY | Drape, Surgical, Ent | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-07 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2009-06-15 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-10-06 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2007-12-18 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 1977-12-23 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 1995-08-01 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2021-08-16 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | Class 1 | 864.3250 | 2002-05-07 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2008-01-16 |
| EYX | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2014-04-11 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 1999-03-30 |
| PRM | Enteral Administration Kit (Adult & Pediatric) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-08-09 |
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2025-08-12 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 1995-08-02 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2016-07-25 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2009-09-03 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2020-08-06 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 1994-05-23 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2006-04-11 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2007-04-26 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2020-10-07 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-17 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2024-10-23 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2013-06-03 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2002-05-07 |
| EYY | Drape, Urological, Disposable | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | Class U | N/A | 2008-01-10 |
| EFQ | Gauze/Sponge, Internal | Unknown | Class U | N/A | 2008-01-10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2016-10-28 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2008-01-17 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2017-04-04 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| GCD | Connector, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2013-07-17 |
| MLN | Electrode, Electrocardiograph, Multi-Function | Cardiovascular | Class 2 | 870.2360 | 2008-01-11 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2008-01-11 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-11 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-11 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2001-06-15 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2018-07-27 |
| BTX | Board, Arm (With Cover), Sterile | General, Plastic Surgery | Class 1 | 878.3910 | 2004-03-22 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2006-05-12 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-06-20 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2005-07-11 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2022-03-22 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2022-03-22 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-09-03 |
| KMJ | Lubricant, Patient | General Hospital | Class 1 | 880.6375 | 2013-12-03 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2023-08-07 |
| HMW | Drape, Microscope, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2007-04-26 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2008-01-11 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2007-12-18 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2017-01-05 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-16 |
| MLS | Labor And Delivery Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2008-06-17 |
| BYZ | Trap, Sterile Specimen | General Hospital | Class 2 | 880.6740 | 2021-06-25 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2019-06-17 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-03 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 1977-12-23 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-05-11 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2005-07-11 |
| FPK | Tubing, Fluid Delivery | General Hospital | Class 2 | 880.5440 | 2008-01-28 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2008-04-24 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 1999-08-04 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 1998-08-17 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2021-08-17 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2007-04-26 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 1995-08-02 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2008-01-16 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2005-04-06 |
| FYC | Gown, Isolation, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2016-07-29 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2017-03-07 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2008-01-28 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | General Hospital | Class 2 | 880.5570 | 2018-06-06 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | Class 2 | 882.5890 | 2008-01-10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2007-12-17 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 1994-02-02 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | Class 2 | 868.5800 | 2008-01-18 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2010-02-03 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2010-10-18 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2008-04-24 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2006-03-20 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2010-08-25 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-15 |
| OWL | Peripheral Catheter Insertion Kit | General Hospital | Class 2 | 880.5200 | 2011-11-11 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2015-08-06 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2014-05-05 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | Class 2 | 880.5970 | 2014-05-05 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-12-03 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2017-06-19 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2014-12-04 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2001-08-31 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2000-08-03 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2001-07-27 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-05 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2017-12-05 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2018-12-19 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2007-04-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2009-10-27 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2026-06-12 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2015-05-14 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2009-05-06 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2021-03-01 |
| OJS | Tourniquet Kit | General, Plastic Surgery | Class 1 | 878.5900 | 2011-11-11 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-02-07 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2024-02-07 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2024-02-07 |
| KNY | Accessories, Catheter, G-U | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-07-27 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2007-12-05 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2001-07-26 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2009-11-02 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2016-06-08 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-16 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2016-07-11 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2007-04-20 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2007-12-18 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 1999-08-04 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-06-02 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-01-06 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-07-20 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-12-11 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-12-11 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | General Hospital | Class 2 | 880.5780 | 2014-09-16 |
| FSY | Light, Surgical, Ceiling Mounted | General, Plastic Surgery | Class 2 | 878.4580 | 2016-08-22 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-10 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004839227 | Cardinal Health Malta 212 Ltd | Marsa, MT |
| 3015541720 | Cardinal Health Germany Manufacturing GmbH | Halberstadt Saxony-Anhalt, DE |
| 1033903 | Cardinal Health | Greenwood, SC, US |
| 9611018 | Cardinal Health Ireland Manufacturing Limited | TULLAMORE Offaly, IE |
| 8040459 | Kendall-Gammatron Limited | SAMPRAN Nakhon Pathom, TH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K010462 | Avita Corporation | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | 2001-04-11 |
| K760421 | Arbrook Mfg. Corp. | THERMOMETER, SURVALENT-ELECTRONIC | 1976-08-23 |
| K813409 | Yellow Springs Instrument Co., Inc. | MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER | 1981-12-18 |
| K830039 | Science Development Corp. | SDC RECTAL TEMP. PROBE PRODUCT #1020 | 1983-02-23 |
| K842199 | Sharp Electronics Corp. | ELEC. DIGITAL THERMOMETER MT-20 & 30 | 1984-07-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Z-0004-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case |
| Z-0006-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1917413 | BECTON, DICKINSON & CO. | BROKEN BOW, NE, US |
| 1061124 | Sterigenics U.S., LLC | Charlotte, NC, US |
| 2029015 | Sterigenics U.S., LLC | Ontario, CA, US |
| 9617032 | Becton, Dickinson & Company (BD) | Plymouth Devon, GB |
| 3013557562 | CBR ENTERPRISE LIMITED | Hong Kong, HK |
1921846 when referencing this establishment in official correspondence.