FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 3002808270
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2018-04-16 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2018-04-13 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2018-04-13 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2018-04-16 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2018-04-16 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-20 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2018-04-13 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2018-04-16 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2018-04-16 |
| JCY | Catheter, Infusion | General, Plastic Surgery | Class 1 | 878.4200 | 2018-04-13 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2016-08-30 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2018-04-13 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2018-04-13 |
| HXJ | Staple Driver | Orthopedic | Class 1 | 888.4540 | 2018-04-16 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2018-04-16 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2018-04-16 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2018-04-13 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-08 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2022-03-09 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-20 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2018-04-16 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-20 |
| MXP | Bone Particle Collector | Ear, Nose, Throat | Class 1 | 874.4800 | 2018-04-13 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| EJE | Frame, Rubber Dam | Dental | Class 1 | 872.6300 | 2018-04-13 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2018-04-13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2022-05-04 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2022-03-09 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2022-03-09 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2018-04-13 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2022-03-09 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2018-04-13 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2018-04-13 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2018-04-16 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2022-03-09 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2018-04-13 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2018-04-13 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2018-04-13 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2018-04-13 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-04-13 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2022-03-09 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2018-04-16 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2018-04-13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2026-06-08 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-20 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2018-04-16 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2018-04-16 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2018-04-13 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2018-04-13 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| EKP | Reamer, Pulp Canal, Endodontic | Dental | Class 1 | 872.4565 | 2018-04-13 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-20 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2018-04-16 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2018-04-16 |
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-20 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-16 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-13 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K831136 | Almore Intl., Inc. | DOUBLE BOW TOOTH SEPARATOR | 1983-06-08 |
| 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-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-0040-2018 | Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446 | 1 | Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis. |
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3012101167 | JOJEN TECHNOLOGIES LLC | Pittsford, NY, US |
| 2183301 | PATTERSON DENTAL SUPPLY, INC. | ST. PAUL, MN, US |
| 3003994666 | NEW PHENIX HOME PRODUCTS MANUFACTORY CO., LTD. | YANGZHOU Jiangsu, CN |
| 3038632739 | TF NEW MATERIAL SCI AND TEC CO.,LTD | Huainan Anhui, CN |
| 1057946 | KLS-Martin L.P. | Jacksonville, FL, US |
3002808270 when referencing this establishment in official correspondence.