FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9616246
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-01-23 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-04-05 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2000-04-05 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2000-09-22 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2009-11-17 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2000-04-05 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2014-10-03 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2000-02-22 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2009-11-17 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-19 |
| HKF | Mirror, Headband, Ophthalmic | Ophthalmic | Class 1 | 886.1500 | 2003-07-25 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2000-03-22 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2000-09-22 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2004-02-11 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2000-06-27 |
| ECN | Clamp, Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2009-05-07 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2000-05-19 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2000-05-18 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2000-05-19 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2000-05-18 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2009-11-17 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2000-06-27 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2013-03-08 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2000-05-19 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2001-11-26 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2000-10-25 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2009-05-12 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2000-02-22 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2000-05-19 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2003-07-25 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2009-12-02 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2000-03-22 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2000-05-18 |
| KBH | Adenotome | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-30 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2000-02-22 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2000-05-19 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2000-10-25 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2000-03-22 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2025-06-17 |
| LGH | Instrument, Cast Removal, Ac-Powered | Orthopedic | Class 1 | 888.5960 | 2002-06-29 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2010-02-23 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2000-05-19 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2000-12-07 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2000-12-07 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2000-06-27 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2000-04-05 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2004-01-07 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2001-05-30 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2009-12-02 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2000-03-22 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2003-07-25 |
| HGN | Stethoscope, Fetal | Obstetrics/Gynecology | Class 1 | 884.2900 | 2001-05-24 |
| DWO | Needle, Biopsy, Cardiovascular | General, Plastic Surgery | Class 1 | 878.4800 | 2003-11-06 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2000-05-19 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2000-09-22 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2004-02-11 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2001-01-29 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-19 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2015-04-28 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2000-05-18 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2004-02-11 |
| JYD | Chisel, Mastoid | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2004-01-07 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2000-06-27 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2000-05-18 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2000-09-22 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2001-05-30 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2000-09-22 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2000-05-18 |
| ECR | Setter, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2001-11-26 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-02-09 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2000-03-22 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2009-05-05 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2000-05-19 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| 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-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1421879 | PHOENIX INSTRUMENTS, INC. | Lisle, IL, US |
| 3008902714 | GARISH APPARELS | Wazirabad Punjab, PK |
| 3029990829 | Bausch & Lomb Incorporated | Eppelheim Baden-Wurttemberg, DE |
| 3004215117 | MILLENNIUM SURGICAL CORP | Schaumburg, IL, US |
| 3006380247 | MEDETZ SURGICAL INSTRUMENTS | Jupiter, FL, US |
9616246 when referencing this establishment in official correspondence.