FDA Device Registration & Listing · STOCKACH Baden-Wurttemberg, DE · Registration 8010732
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2005-12-15 |
| EMP | Marker, Periodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EMQ | Hoe, Periodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 1996-12-17 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2005-12-20 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2005-12-15 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| DZP | Instrument, Diamond, Dental | Dental | Class 1 | 872.4535 | 1996-12-16 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 1996-12-17 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 1996-12-17 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 1996-12-16 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2005-12-15 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| HXR | Spatula, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 1996-12-17 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 1996-12-16 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2013-01-18 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2005-12-15 |
| EBR | Unit, Suction Operatory | Dental | Class 1 | 872.6640 | 2017-09-06 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2005-12-15 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EKF | Instrument, Contouring, Matrix, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 1996-12-17 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 1996-12-16 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 1996-12-16 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2005-12-15 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2005-12-15 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 1996-12-16 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-17 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 1996-12-17 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 1996-12-16 |
| 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 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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. |
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0012-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0013-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9613926 | Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, IN |
| 3008711893 | B.Braun Medical (Suzhou) Co,.Ltd | Suzhou Jiangsu, CN |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
| 3010687973 | FETZER SURGICAL, LLC | Scottsdale, AZ, US |
| 3016965929 | COMFORT SURGICAL INSTRUMENTS | Sialkot Punjab, PK |
8010732 when referencing this establishment in official correspondence.