FDA Device Registration & Listing · Manchester, GB · Registration 3001084743
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2017-09-06 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-27 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-27 |
| OJV | Single Use Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-16 |
| PVT | Maternity Kit | Obstetrics/Gynecology | Class 1 | 884.5435 | 2023-06-30 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-27 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-09-25 |
| OGR | Ear, Nose, And Throat Surgical Tray | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-05-16 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2002-08-21 |
| KYS | Insoles, Medical | General Hospital | Class 1 | 880.6280 | 2002-08-21 |
| MCY | Wound Dressing Kit | General Hospital | Class 2 | 880.5075 | 2023-06-30 |
| GXB | Esthesiometer | Neurology | Class 1 | 882.1500 | 2002-08-21 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-03-24 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2023-06-27 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| GWZ | Percussor | Neurology | Class 1 | 882.1700 | 2002-08-21 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-06-27 |
| MCZ | Suture Removal Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-30 |
| KNP | Orthosis, Corrective Shoe | Physical Medicine | Class 1 | 890.3475 | 2023-06-27 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-09-25 |
| GWI | Discriminator, Two-Point | Neurology | Class 1 | 882.1200 | 1998-04-21 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-09-25 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2017-09-06 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| OVN | Suture Kit | General, Plastic Surgery | Class 2 | 878.4830 | 2023-06-30 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2023-06-27 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2023-06-27 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2002-08-21 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-06-27 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-27 |
No official correspondent registered.
| 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-0029-2025 | Windstone Medical Packaging, Inc. | 1 | Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. |
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1424263 | Isomedix Operations, Inc. | Libertyville, IL, US |
| 2183570 | MCLEAN MEDICAL & SCIENTIFIC | Saint Paul, MN, US |
| 3006017180 | BBF STERILISATIONSSERVICE GMBH | Kernen Baden-Wurttemberg, DE |
| 2133928 | Metal Craft Machine & Engineering, Inc. | Elk River, MN, US |
| 3011024991 | Nypro Inc (Maple Grove) | Maple Grove, MN, US |
3001084743 when referencing this establishment in official correspondence.