FDA Device Registration & Listing · Torshalla Sodermanland, SE · Registration 3003696170
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2013-01-28 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2009-03-13 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2009-03-13 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2011-02-04 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2009-03-13 |
| IWQ | Curtain, Protective, Radiographic | Radiology | Class 1 | 892.6500 | 2013-01-28 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2009-03-13 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2009-03-13 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2009-03-13 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-28 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2009-03-13 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| LGX | Table, Examination, Medical, Powered | General, Plastic Surgery | Class 1 | 878.4960 | 2003-05-30 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | Class 1 | 878.4960 | 2003-05-30 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-11-12 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2009-03-13 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2009-03-13 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K894785 | Fdt Precision Machine Co., Inc. | SURGICAL CHISEL/OSTEOTOME | 1989-08-18 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010359335 | DAIWA MARKANT INDUSTRY LTD | SAKAI Osaka, JP |
| 2436880 | Dri Mark Products, Inc. | Bethpage, NY, US |
| 3004513650 | RMAC SURGICAL INC | Etobicoke Ontario, CA |
| 1928237 | MIDWEST STERILIZATION CORP. | JACKSON, MO, US |
| 9612030 | Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, MX |
3003696170 when referencing this establishment in official correspondence.