FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010099
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2002-03-07 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2002-03-07 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2007-08-09 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-09 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2011-04-18 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2002-06-19 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2002-06-01 |
| HSP | Splint, Traction | Orthopedic | Class 1 | 888.5890 | 1998-09-23 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2000-09-08 |
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 2007-08-09 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-06 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1998-09-23 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-01 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-09 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-07 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-06 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-06 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2002-03-07 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-03-13 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2007-01-29 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2007-08-09 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2002-07-11 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2017-05-06 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-07 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2002-03-07 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2002-06-19 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2002-06-01 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1998-09-23 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-07-11 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 1978-06-20 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2002-08-21 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 1998-09-21 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2012-06-22 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2007-08-09 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 1978-06-20 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2007-12-17 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2007-08-09 |
| HNT | Erisophake | Ophthalmic | Class 1 | 886.4350 | 2002-06-06 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2002-06-06 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-06 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2002-06-19 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2017-06-17 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2020-04-03 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2002-06-06 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-07 |
| HCH | Clip, Aneurysm | Neurology | Class 2 | 882.5200 | 2007-12-18 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2002-03-07 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2011-02-16 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-06-06 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2002-03-07 |
| DZC | Wire, Orthodontic | Dental | Class 1 | 872.5410 | 1998-09-18 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2007-12-17 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 1998-09-23 |
| JZY | Knife, Laryngeal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-19 |
| SFA | Prosthesis, Finger, Semi-Constrained, Metal/Polymer | Unknown | Class 3 | N/A | 2025-07-21 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 1998-09-23 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2002-07-11 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-06-19 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2002-07-11 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2007-08-09 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2007-08-09 |
| HCI | Applier, Aneurysm Clip | Neurology | Class 2 | 882.4175 | 2007-12-18 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1978-06-20 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-07 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2001-09-27 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2002-06-01 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2007-12-18 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-08-09 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2007-08-09 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2011-04-20 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-19 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2026-04-07 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-09 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-02-22 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 1998-09-23 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2002-06-06 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-01 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-03-07 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2002-03-07 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-08-09 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 1998-09-18 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2002-04-24 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2004-12-30 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-09 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-06 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-08-09 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2002-03-07 |
| EGG | Attachment, Precision, All | Dental | Class 1 | 872.3165 | 2025-04-16 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2011-04-19 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2007-08-09 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2010-02-10 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2025-03-28 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2002-07-11 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2007-12-17 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2007-12-17 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-19 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1978-06-20 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 1998-09-23 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-08-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-06-17 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2008-01-17 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 1978-06-20 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2007-08-09 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2006-06-14 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2017-02-02 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2010-12-14 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2007-08-09 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 1997-06-10 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2017-02-02 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2011-04-18 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-07-11 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2007-12-18 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2002-09-18 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2002-06-01 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2007-08-09 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2002-07-11 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-19 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2002-03-07 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | Class 2 | 888.3060 | 2022-05-03 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2002-03-07 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2007-08-09 |
| HPN | Magnet, Permanent | Ophthalmic | Class 1 | 886.4445 | 2002-06-19 |
| DZL | Screw, Fixation, Intraosseous | Dental | Class 2 | 872.4880 | 2017-06-17 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2002-03-07 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-08-09 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-07-11 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-08-09 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2002-06-01 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-08-09 |
| FZE | Prosthesis, Nose, Internal | General, Plastic Surgery | Class 2 | 878.3680 | 2025-04-16 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2002-07-11 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2002-03-07 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 1998-09-18 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2008-01-17 |
| KBP | Hook, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 1998-09-21 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2002-03-07 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2007-08-09 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2002-06-06 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2002-03-07 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-06-19 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2002-06-06 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2002-06-01 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3002862271 | Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, DE |
| 3022747125 | Stehle Medizintechnik | Renquishausen Baden-Wurttemberg, DE |
| 3013497507 | Teufel & Gerlach GmbH | Tuttlingen Baden-Wurttemberg, DE |
| 3003322138 | Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, DE |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K163363 | Surgtech, Inc. | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | 2017-04-05 |
| K252461 | Spinal Resources, Inc. | Swedge Pedicle Screw Fixation System Bezier Rod | 2026-01-13 |
| K140696 | Pioneer Surgical Technology, Inc. | STREAMLINE TL SPINAL FIXATION SYSTEM | 2014-04-10 |
| K141398 | Medicrea International SA | PASS LP SPINAL SYSTEM | 2015-01-09 |
| K160980 | Spineology, Inc. | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | 2016-05-26 |
| 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-0001-2013 | Synthes USA HQ, Inc. | 2 | MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine.
The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). |
| Z-0004-2008 | Abbott Spine | 2 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50. |
| Z-0005-2008 | Abbott Spine | 2 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60. |
| Z-0020-06 | Pioneer Surgical Technology | 2 | Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005973280 | EMERALD INSTRUMENTS | SIALKOT Punjab, PK |
| 8040263 | GLORIOUS MERCANTILE CORP. (PVT) LTD. | SIALKOT Punjab, PK |
| 3010699884 | ALFRAMED | Sialkot Punjab, PK |
| 9611283 | DIMEDA INSTRUMENTE GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
8010099 when referencing this establishment in official correspondence.