FDA Device Registration & Listing · Austell, GA, US · Registration 3004824601
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-29 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2014-12-29 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2019-08-12 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2014-12-29 |
| KNO | Accessories, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2014-12-29 |
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | Class 1 | 880.5150 | 2014-12-29 |
| NDA | Helmet, Cranial, For Protective Use | Physical Medicine | Class 1 | 890.3025 | 2014-12-29 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2019-08-12 |
| IKW | Utensil, Homemaking | Physical Medicine | Class 1 | 890.5050 | 2014-12-29 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2014-12-29 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2019-08-12 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-29 |
| KMN | Chair And Table, Medical | General Hospital | Class 1 | 880.6140 | 2014-12-29 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2017-05-01 |
| ILT | Adaptor, Recreational | Physical Medicine | Class 1 | 890.5050 | 2014-12-29 |
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | Hematology | Class 2 | 864.6400 | 2022-11-08 |
| IPR | Crutch | Physical Medicine | Class 1 | 890.3150 | 2019-08-12 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | Class 1 | 868.5975 | 2019-08-12 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-07-29 |
| IMA | Pack, Heat, Moist | Physical Medicine | Class 1 | 890.5730 | 2014-12-29 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2014-12-29 |
| GXB | Esthesiometer | Neurology | Class 1 | 882.1500 | 2014-12-29 |
| IQK | Orthosis, Cervical | Physical Medicine | Class 1 | 890.3490 | 2014-12-29 |
| IOY | Support, Arm | Physical Medicine | Class 1 | 890.3475 | 2014-12-29 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2014-12-29 |
| IKX | Aid, Transfer | Physical Medicine | Class 1 | 890.5050 | 2014-12-29 |
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | Class 1 | 878.4040 | 2014-12-29 |
| BXJ | Clip, Nose | Anesthesiology | Class 1 | 868.6225 | 2014-12-29 |
| FPF | Bottle, Hot/Cold Water | General Hospital | Class 1 | 880.6085 | 2021-12-09 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2014-12-29 |
| IOD | Components, Exercise | Physical Medicine | Class 1 | 890.5350 | 2014-12-29 |
| IMZ | Holder, Crutch And Cane, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2014-12-29 |
| ILD | Adaptor, Dressing | Physical Medicine | Class 1 | 890.5050 | 2014-12-29 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-12 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2014-12-29 |
| IMY | Armboard, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2014-12-29 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2019-08-12 |
| HRW | Dynamometer, Nonpowered | Orthopedic | Class 1 | 888.1250 | 2014-12-29 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2019-08-12 |
| IPS | Cane | Physical Medicine | Class 1 | 890.3075 | 2014-12-29 |
| FOD | Device, Occlusion, Umbilical | General Hospital | Class 1 | 880.5950 | 2014-12-29 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2014-12-29 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2014-12-29 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2019-08-12 |
| KNP | Orthosis, Corrective Shoe | Physical Medicine | Class 1 | 890.3475 | 2019-08-12 |
| HST | Apparatus, Traction, Non-Powered | Orthopedic | Class 1 | 888.5850 | 2014-12-29 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 2014-12-29 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-07-29 |
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | Class 1 | 880.5420 | 2019-08-12 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| K915446 | Sun Glitz Corp. | STRETCH WRAP | 1992-05-06 |
| K833120 | Acme United Corp. | ONE TIME COMPOUND BENZOIN TINCTURE- | 1983-12-29 |
| K870091 | Avery Intl. | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | 1987-02-04 |
| K880871 | John Wagner Associates, Inc. | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | 1988-05-20 |
| 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-0031-2026 | Percussionaire Corporation | 1 | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use |
| Z-0030-2014 | Perkin Elmer Health Sciences, Inc. | 2 | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900.
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information. |
| Z-0006-2025 | Ossur H F Grjothals 5 Reykjavik Iceland | 1 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007031057 | MERCIAN SURGICAL SUPPLY CO LTD | Bromsgrove Worcestershire, GB |
| 3011693567 | LAMINATE MEDICAL TECHNOLOGIES | Tel Aviv, IL |
| 3009134882 | DMED | Seongnam-si Gyeonggi, KR |
| 1057425 | SOUTHEASTERN TECHNOLOGY dba Autocam Medical | Murfreesboro, TN, US |
| 8044098 | HGR INSTRUMENTE GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
3004824601 when referencing this establishment in official correspondence.