FDA Device Registration & Listing · Emmingen-Liptingen Baden-Wurttemberg, DE · Registration 8010547
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 |
|---|---|---|---|---|---|
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 1985-06-18 |
| KQW | Goniometer, Nonpowered | Orthopedic | Class 1 | 888.1520 | 1998-01-09 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-31 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 1998-01-09 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 1983-09-27 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1985-06-18 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-12-13 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 1985-06-18 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 1998-01-09 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1986-05-15 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 1998-01-09 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2012-12-13 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 1986-05-15 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2012-12-13 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1985-06-18 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 1998-01-09 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 1997-09-09 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 1998-01-09 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-11-14 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1985-06-18 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1997-07-11 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-31 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 1998-01-09 |
| KAJ | Mobilizer, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1998-01-09 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-13 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 1997-06-25 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 1998-01-09 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 1985-06-18 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2012-12-13 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 1986-05-15 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 1985-06-18 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 1998-01-09 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 1983-09-27 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1998-01-09 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| 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 |
|---|---|---|
| 3003536766 | MIQRAZ SURGICAL INDUSTRIES | Sialkot Punjab, PK |
| 1932180 | Bausch & Lomb Incorporated | Manchester, MO, US |
| 3003334541 | CONCISE ENTERPRISES | Sialkot Punjab, PK |
| 3004892425 | SPARTECH INSTRUMENTS & CO. | SIALKOT, PUNJAB, PK |
| 9680735 | HERMANN MUELLER Medizintechnik GmbH | TUTTLINGEN Baden-Wurttemberg, DE |
8010547 when referencing this establishment in official correspondence.