FDA Device Registration & Listing · NEUHAUSEN OB ECK Baden-Wurttemberg, DE · Registration 3005621335
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2007-10-30 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2020-09-04 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2007-10-30 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-10-30 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-03-20 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2006-03-01 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2020-03-20 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2020-03-20 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2007-10-30 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2006-03-01 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2007-10-30 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-03-01 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2020-03-20 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2007-10-30 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2006-03-01 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2007-10-30 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2020-03-19 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2020-03-20 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2020-03-20 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2006-03-01 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2007-10-30 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2020-03-19 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-10-30 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2007-10-30 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2007-10-30 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2006-03-01 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-03-20 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2020-03-20 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 2020-03-20 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2006-03-01 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2020-03-20 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2007-10-30 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2007-10-30 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2006-03-01 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2006-03-01 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2007-10-30 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2020-03-20 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9680002 | MARYAM TRADING | SIALKOT Punjab, PK |
| 3010155661 | Synergy Health Sterilisation UK Ltd | Thorne Doncaster, GB |
| 3004193466 | HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC | Emmingen-Liptingen Baden-Wurttemberg, DE |
| 3003431869 | HILBRO INTERNATIONAL (PVT) LIMITED | SIALKOT Punjab, PK |
| 2916714 | AESCULAP, INC. | CENTER VALLEY, PA, US |
3005621335 when referencing this establishment in official correspondence.