FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9612074
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-14 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 1987-11-11 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 1999-08-10 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-05-17 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2015-11-19 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 1986-05-06 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 1990-04-19 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 1986-05-06 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 1986-05-20 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1990-04-19 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-07-17 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 1990-12-27 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1986-09-29 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 1987-02-18 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1985-03-21 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-05-17 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 1987-03-02 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2024-07-17 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2024-07-17 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2007-11-27 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | Obstetrics/Gynecology | Class 2 | 884.4530 | 2007-11-27 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2007-11-27 |
| HDC | Tenaculum, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2007-11-27 |
| HHO | Screw, Fibroid, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2007-11-27 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 1987-03-02 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1987-05-05 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-12-10 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 1989-03-28 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1989-07-21 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1987-06-30 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 1987-02-18 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 1987-01-26 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 1987-09-11 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 1987-03-11 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 1990-04-19 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2020-06-02 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-23 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-23 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-23 |
| OWN | Confocal Optical Imaging | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-23 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 1987-02-18 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 1990-04-19 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 1989-07-21 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 1989-03-28 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-01-18 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 1992-08-12 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1990-04-19 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1987-04-01 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2020-06-02 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1990-04-19 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2025-09-30 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 1987-03-11 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 1992-12-22 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1989-03-28 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 1989-07-21 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2025-03-25 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1987-09-11 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2010-07-21 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-03-27 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2025-03-27 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2020-06-02 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1987-04-01 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2008-01-25 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1987-03-11 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 1983-09-27 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 1987-04-01 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 1986-05-21 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 1987-02-18 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-05-17 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 1987-03-02 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2025-11-25 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-07-17 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1992-06-15 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 1985-03-21 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2020-06-02 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2024-11-29 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2024-11-29 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2020-06-02 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 1991-01-28 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-06-02 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 1987-03-18 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2025-03-25 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-23 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1987-05-05 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 1998-11-25 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-09-21 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-14 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1987-02-18 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 1991-01-28 |
| HGE | Amniotome | Obstetrics/Gynecology | Class 1 | 884.4530 | 1992-12-22 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1989-09-15 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-09 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K970809 | Somnus Medical Technologies, Inc. | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | 1997-06-18 |
| K222793 | C.R. Bard, Inc. | WavelinQ Generator | 2022-10-17 |
| K002257 | Tecno Instruments (Pvt.) , Ltd. | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | 2000-10-19 |
| K193591 | Bowa-Electronics GmbH & Co. KG | ARC 400 | 2020-04-02 |
| K192128 | Sutter Medizintechnik GmbH | Sutter Arrowtip Monopolar Electrodes | 2019-10-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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 |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| 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-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3029082594 | CHOOSE SURGICAL INSTRUMENTS | Sialkot Punjab, PK |
| 3006410968 | ROBINSON HEALTHCARE LIMITED | Worksop Nottinghamshire, GB |
| 3004598675 | WASHINGTON SURGICAL INTERNATIONAL | SIALKOT Punjab, PK |
| 9614084 | MEDICAL DEVICES (PVT) LTD. | Sialkot Punjab, PK |
| 3003644849 | DR. FRIGZ INTERNATIONAL (PVT) LTD. | SIALKOT, Punjab, PK |
9612074 when referencing this establishment in official correspondence.