FDA Device Registration & Listing · Tuttlingen-Nendingen Baden-Wurttemberg, DE · Registration 3035678069
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-12-19 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2024-12-16 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-19 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-28 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-29 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-28 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-29 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-28 |
| FHK | Spreader, Bladder Neck | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-29 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-28 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2024-12-19 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2024-12-29 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-28 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2024-12-19 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-29 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-12-28 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-29 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-28 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2024-12-28 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2024-12-29 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-28 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-28 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-19 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2024-12-19 |
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | Class 1 | 884.1720 | 2024-12-28 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-12-29 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2024-12-28 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2024-12-28 |
| KAC | Tube, Laryngectomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-29 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2024-12-29 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-29 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-28 |
| GBQ | Catheter, Continuous Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2024-12-29 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-28 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-29 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-12-19 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-29 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2024-12-28 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 2024-12-19 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-29 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-19 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2024-12-29 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-29 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-19 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| EAJ | Apron, Leaded | Radiology | Class 1 | 892.6500 | 2024-12-29 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-29 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2024-12-29 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-29 |
| FFD | Evacuator, Bladder, Manually Operated | Gastroenterology, Urology | Class 1 | 876.4370 | 2024-12-29 |
| NWW | Hysteroscope Accessories | Obstetrics/Gynecology | Class 1 | 884.1690 | 2024-12-19 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-28 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-29 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-29 |
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | Class 1 | 878.4960 | 2024-12-29 |
| HGD | Applicator, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-12-19 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2024-12-19 |
| FHM | Apparatus, Suturing, Stomach And Intestinal | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-19 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-19 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2024-12-29 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-12-19 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-12-28 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0040-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0041-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Catalog Number: 72201714
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0042-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Catalog Number: 72201715
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0043-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 6mm Offset (Green)
Catalog Number: 72201716
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0044-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 7mm Offset (Gold)
Catalog Number: 72201717
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005374323 | SPECTRUM SURGICAL SUPPLIES | SIALKOT Punjab, PK |
| 3043226252 | ZAPALIGN LLC | Fort Lauderdale, FL, US |
| 1421879 | PHOENIX INSTRUMENTS, INC. | Lisle, IL, US |
| 1123010 | TRINITY STERILE, INC. | SALISBURY, MD, US |
| 3017521423 | Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, DE |
3035678069 when referencing this establishment in official correspondence.