FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9680718
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 1999-04-15 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1995-08-10 |
| GCI | Laryngoscope, Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-01-13 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2009-02-12 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-03-19 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 2023-08-31 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2009-06-05 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-12-16 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 1996-02-09 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 1997-07-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-07-28 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-04-05 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2019-04-05 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2005-09-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2008-07-27 |
| ISN | Cable | Physical Medicine | Class 1 | 890.3420 | 2005-05-03 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2003-12-22 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2014-12-16 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 1996-04-01 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-24 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2014-12-15 |
| FWF | Camera, Television, Endoscopic, Without Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2009-02-18 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-16 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2005-09-28 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-15 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1997-05-12 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 1996-03-07 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2008-09-17 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 1996-03-18 |
| EYI | Adaptor, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2023-08-31 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-27 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2014-12-16 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-13 |
| FCT | Headlight, Fiberoptic Focusing | Ophthalmic | Class 2 | 886.4335 | 2016-09-21 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 1996-02-09 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-20 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 1995-07-27 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1998-01-06 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 1995-12-20 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2009-06-05 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2008-07-27 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2005-09-28 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2009-01-07 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1995-11-29 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 1996-01-16 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 1998-05-15 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-07-27 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2008-07-27 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-15 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2014-12-16 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2014-12-15 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2008-07-27 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2003-10-03 |
| HNK | Probe, Trabeculotomy | Ophthalmic | Class 1 | 886.4350 | 2009-06-03 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1999-10-28 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2009-06-03 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-10-10 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 1997-12-03 |
| NWW | Hysteroscope Accessories | Obstetrics/Gynecology | Class 1 | 884.1690 | 2010-07-07 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-27 |
| HMQ | Marker, Sclera | Ophthalmic | Class 1 | 886.4570 | 2006-10-10 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2003-10-03 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2006-10-10 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2008-07-27 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-07-27 |
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-08-31 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 1997-07-11 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2014-12-17 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1998-01-05 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1995-10-12 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2021-12-06 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2009-02-12 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2008-07-27 |
| EYK | Connector, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2023-08-31 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 1995-08-03 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2005-09-28 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-25 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 1995-09-20 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2009-02-18 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-24 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2008-07-27 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2014-12-17 |
| KQT | Evacuator, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.4370 | 2005-09-28 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 1995-07-27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2009-03-19 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 1995-07-20 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2023-08-31 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1995-12-19 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2005-09-28 |
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | Class 1 | 878.4200 | 2008-07-27 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2009-06-05 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-12-16 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-24 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2023-08-31 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | Class 1 | 880.6350 | 2014-12-17 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2014-12-16 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2010-02-24 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| FFD | Evacuator, Bladder, Manually Operated | Gastroenterology, Urology | Class 1 | 876.4370 | 2009-03-20 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 1996-10-29 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2009-06-05 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1996-03-05 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-14 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 1996-01-16 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2014-12-14 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-11 |
| FHK | Spreader, Bladder Neck | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-24 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2009-05-30 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-12-16 |
| LQC | Lithotriptor, Biliary Mechanical | Gastroenterology, Urology | Class 2 | 876.4500 | 2025-07-08 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 1996-02-27 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 1998-12-30 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2023-08-31 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1995-08-16 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1995-12-26 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-02-12 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2023-08-31 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1994-07-05 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 2009-02-18 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2014-12-14 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 1995-09-25 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| HNG | Rongeur, Lachrymal Sac | Ophthalmic | Class 1 | 886.4350 | 2009-06-03 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2019-04-05 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2019-04-05 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-04-05 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 1997-08-06 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-31 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-15 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2008-11-17 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-06-09 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 1996-03-19 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 1995-07-10 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-15 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-24 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| HLN | Gauge, Lens, Ophthalmic | Ophthalmic | Class 1 | 886.1420 | 1995-10-23 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1996-12-04 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-10-10 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Ophthalmic | Class 1 | 886.4350 | 2009-06-05 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 1996-07-26 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2005-09-28 |
| FSW | Light, Surgical, Endoscopic | General, Plastic Surgery | Class 2 | 878.4580 | 2023-08-31 |
| GXJ | Punch, Skull | Neurology | Class 1 | 882.4750 | 2014-12-15 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 1996-01-16 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 1995-09-18 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2010-02-24 |
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 1997-05-15 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2003-10-03 |
| FSE | Table, Operating-Room, Manual | General, Plastic Surgery | Class 1 | 878.4950 | 2009-02-12 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| K254228 | Karl Storz SE & CO. KG | KARL STORZ Trocars with Valve Seals | 2026-05-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| 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 |
| Z-0023-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3011371465 | SINNTECH MEDICAL (PRIVATE) LIMITED | Sialkot Punjab, PK |
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 3031564283 | VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED | Sialkot Punjab, PK |
| 3008902714 | GARISH APPARELS | Wazirabad Punjab, PK |
| 3003877407 | ZAIN'S MEDICAL IMAGE | SIALKOT Punjab, PK |
9680718 when referencing this establishment in official correspondence.