FDA Device Registration & Listing · Lincolnshire, IL, US · Registration 3007407626
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2023-03-13 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2021-08-25 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2023-03-13 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-13 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2022-05-04 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2021-08-25 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2023-03-13 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-05-29 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2024-02-27 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2021-08-25 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2023-11-27 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2022-12-09 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-08-25 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-13 |
| FRI | Scale, Stand-On, Patient | General Hospital | Class 1 | 880.2700 | 2023-01-26 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2021-08-25 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-08-25 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2021-08-25 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-11-27 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2023-11-27 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2023-11-27 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-11-27 |
| IRT | Pad, Heating, Powered | Physical Medicine | Class 2 | 890.5740 | 2022-12-09 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-10 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2025-12-10 |
| FRW | Scale, Patient | General Hospital | Class 1 | 880.2720 | 2023-01-26 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2022-12-09 |
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | Class 1 | 880.5420 | 2025-12-10 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2021-08-25 |
| FME | Gown, Examination | General Hospital | Class 1 | 880.6265 | 2021-08-25 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2023-05-10 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2024-09-25 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2023-03-13 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-08-25 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2021-08-25 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2021-08-25 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K880871 | John Wagner Associates, Inc. | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | 1988-05-20 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| K760422 | Cutter Laboratories, Inc. | SURGICAL RETRACTOR | 1976-08-23 |
| K880350 | Honway International Co. | YUE/FA DISPOSABLE SYRINGE | 1988-02-16 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0505-2022 | Philips North America Llc | 1 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 |
| Z-0506-2022 | Philips North America Llc | 1 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3024689458 | CPM Solutions | South Windsor, CT, US |
| 3031595576 | SUZHOU SMH CO., LTD. | Suzhou Jiangsu, CN |
| 3017103360 | RAIN EYE DROPS LLC | Wilmington, DE, US |
| 3003255790 | WITKO INCORPORATED | Wolcott, IN, US |
| 3008742818 | PT. Hisamitsu Pharma Indonesia | Sidoarjo Jawa Timur, ID |
3007407626 when referencing this establishment in official correspondence.