DIMEDA INSTRUMENTE GMBH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9611283

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611283
FEI Number
3002806816
Entity Name
DIMEDA INSTRUMENTE GMBH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
GANSACKER 54 + 58, TUTTLINGEN Baden-Wurttemberg D-78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
DIMEDA INSTRUMENTE GMBH (Owner Number: 8010631)
Owner / Operator Contact Address
GANSACKER 54 + 58, --, TUTTLINGEN, DE-BW D-78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA DIMEDA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KAY Punch, Nasal Ear, Nose, Throat Class 1 874.4420 1994-02-18
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 1994-02-18
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1985-06-05
JYP Knife, Myringotomy Ear, Nose, Throat Class 1 874.4420 1994-02-18
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-02-18
KCE Cannulae, Bronchial General, Plastic Surgery Class 1 878.4800 1994-02-17
HOB Clamp, Muscle, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
JXX Forceps, Wire Closure, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2000-03-28
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 1994-02-17
GXJ Punch, Skull Neurology Class 1 882.4750 1994-02-18
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 1994-02-17
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
KCI Trocar, Tracheal Ear, Nose, Throat Class 1 874.4420 1994-02-18
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 1994-02-18
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 1994-02-18
HXD Clamp General, Plastic Surgery Class 1 878.4800 1994-02-18
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 1994-02-18
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2000-03-28
HTD Forceps General, Plastic Surgery Class 1 878.4800 2000-03-28
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 1994-02-18
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 1994-02-17
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2003-03-17
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 1992-12-04
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2003-03-17
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 1994-02-17
HWM Osteotome General, Plastic Surgery Class 1 878.4800 1994-02-18
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2003-02-11
JEX Plier, Orthodontic Dental Class 1 872.4565 2010-03-18
EKG Condenser, Amalgam And Foil, Operative Dental Class 1 872.4565 1994-02-17
GWZ Percussor Neurology Class 1 882.1700 2009-10-28
KIL Positioner, Socket Orthopedic Class 1 888.4540 2003-02-11
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 1994-02-18
EIG Retractor, All Types Dental Class 1 872.4565 1994-02-18
HWX Tap, Bone Orthopedic Class 1 888.4540 1994-02-17
GEF Applier, Staple, Surgical, General, Plastic Surgery Class 1 878.4800 1994-02-17
HXZ Cutter, Wire Orthopedic Class 1 888.4540 1994-02-18
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 1994-02-18
HXJ Staple Driver Orthopedic Class 1 888.4540 1994-02-18
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1985-06-05
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 1994-02-18
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2003-02-11
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 1994-02-18
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 1994-02-18
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-02-18
HTX Rongeur Orthopedic Class 1 888.4540 1994-02-18
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 1994-02-18
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
FNS Ring Cutter General Hospital Class 1 880.6200 1994-02-18
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1994-02-18
EJY Pliers, Operative Dental Class 1 872.4565 2010-03-18
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2003-03-17
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1994-02-17
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 1994-02-18
HBR Rack, Clip Neurology Class 1 882.4215 1994-02-18
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 1994-02-18
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2003-03-17
KAO Curette, Ethmoid Ear, Nose, Throat Class 1 874.4420 1994-02-18
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1994-02-18
HJJ Lens, Fresnel, Flexible, Diagnostic Ophthalmic Class 1 886.1390 2003-03-17
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 1994-02-18
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 1994-02-18
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2010-04-28
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2003-02-11
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 2003-03-17
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 1994-02-17
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1994-02-18
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 1994-02-17
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 1994-02-18
HTF Curette General, Plastic Surgery Class 1 878.4800 1994-02-18
DWH Blade, Saw, Surgical, Cardiovascular General, Plastic Surgery Class 1 878.4820 1994-02-17
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 1994-02-18
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2003-02-11
EKE Curette, Operative Dental Class 1 872.4565 1994-02-18
JZA Rongeur, Mastoid Ear, Nose, Throat Class 1 874.4420 1994-02-18
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-02-11
HSS Halter, Head, Traction Orthopedic Class 1 888.5890 1994-02-18
EIK Carver, Wax, Dental Dental Class 1 872.4565 2011-02-28
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2003-03-17
HMZ Trabeculotome Ophthalmic Class 1 886.4350 1994-02-18
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2003-02-11
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 1994-02-18
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 1994-02-18
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2009-07-27
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 1994-02-18
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1985-06-05
EMD Hemostat, Surgical Dental Class 1 872.4565 1992-12-04
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2010-03-30
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 1994-02-18
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 1994-02-17
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 1992-12-04
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 1994-02-18
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2003-03-17
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 1994-02-17
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2011-01-18
HNG Rongeur, Lachrymal Sac Ophthalmic Class 1 886.4350 1994-02-18
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2009-10-19
FHK Spreader, Bladder Neck Gastroenterology, Urology Class 1 876.4730 1994-02-17
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 1994-02-17
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1994-02-18
KCC Bistoury, Tracheal Ear, Nose, Throat Class 1 874.4420 1994-02-18
GWX Fork, Tuning Neurology Class 1 882.1525 1994-02-18
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 1994-02-17
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2003-03-17
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 1994-02-17
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2003-02-11
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 1994-02-18
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1994-02-18
HNT Erisophake Ophthalmic Class 1 886.4350 1994-02-18
HXS Twister, Wire Orthopedic Class 1 888.4540 1994-02-18
EMI File, Bone, Surgical Dental Class 1 872.4565 1994-02-17
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
GAG Stapler, Surgical General Hospital Class 2 878.4740 2003-02-11
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 1994-02-18
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 1985-06-05
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 1985-06-05
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-03-17
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1994-02-17
HXY Brace, Drill Orthopedic Class 1 888.4540 1994-02-17
KBX Screw, Tonsil Ear, Nose, Throat Class 1 874.4420 1994-02-18
JYI Gauge, Mastoid Ear, Nose, Throat Class 1 874.4420 1994-02-18
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 1994-02-18
JBS Timer, General Laboratory Clinical Chemistry Class 1 862.2050 1994-02-18
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-02-18
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1994-02-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1985-06-05
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 1994-02-18
KCL Blower, Powder, Ent Ear, Nose, Throat Class 1 874.5220 1994-02-17
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1985-06-05
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 1994-02-18
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-02-18
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 1994-02-18
HXX Screwdriver Orthopedic Class 1 888.4540 1994-02-18
GWY Pinwheel Neurology Class 1 882.1750 1994-02-18
HXC Wrench Orthopedic Class 1 888.4540 1994-02-18
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 1994-02-18
HTO Reamer Orthopedic Class 1 888.4540 1994-02-18
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2009-07-27
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 1994-02-18
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 1994-02-17
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 1994-02-17
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 1994-02-17
KBT Punch, Tonsil Ear, Nose, Throat Class 1 874.4420 1994-02-18
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 1994-02-18
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 1994-02-18
EMR File, Periodontic Dental Class 1 872.4565 1994-02-17
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 1994-02-17
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1994-02-18
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 1994-02-18
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 1994-02-18
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 1994-02-18
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2011-02-28
JXT Crimper, Wire, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 1994-02-18
FNY Basin, Emesis General Hospital Class 1 880.6730 1994-02-17
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 1994-02-17
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2010-03-12
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1994-02-18
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1994-02-17
ECT Driver, Band, Orthodontic Dental Class 1 872.4565 1994-02-18
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 1994-02-17
KBP Hook, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 1994-02-18
HXN Applier, Cerclage Orthopedic Class 1 888.4540 1994-02-17
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 1994-02-18
HXB Probe Orthopedic Class 1 888.4540 1994-02-18
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 1994-02-18
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 1994-02-18
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 1994-02-18
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 1994-02-18
JZE Spoon, Ear Ear, Nose, Throat Class 1 874.4420 1994-02-18
EAX Mirror, Mouth Dental Class 1 872.4565 1994-02-18
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2010-07-29
KCA Tonsillectome Ear, Nose, Throat Class 1 874.4420 1994-02-18

Official Correspondent

Artur Dukart

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

DIMEDA INSTRUMENTE GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

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
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K871646 Ocular Instruments, Inc. TANNE CORNEAL CUTTING BLOCK 1987-05-18
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611283. Last updated year: 2026. Please use registration number 9611283 when referencing this establishment in official correspondence.
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