CM INSTRUMENTE GMBH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9680518

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
9680518
FEI Number
3005304066
Entity Name
CM INSTRUMENTE GMBH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
GANSACKER 56, TUTTLINGEN Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CM INSTRUMENTE GMBH (Owner Number: 9009573)
Owner / Operator Contact Address
GANSACKER 56, --, TUTTLINGEN, DE-BW 78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CM ENT WIRE CUTTING SCISSORS CM -Instrumente CM TONSIL KNIFE CM -Instrumente WRENCH CM -Instrumente CM ENT SPECULUM CM -Instrumente CM -Instrumente CM ENT KNIFE CM ENT WIRE CLOSURE FORCEPS CM -Instrumente CM OPHTHALMIC CURETTE CM -Instrumente CM -Instrumente FORCEPS WIRE HOLDING CM ENT NASAL GOUGE CM -Instrumente CM CONTAINER CM -Instrumente EXTRACTOR CM -Instrumente CM WIRE TWISTER CM -Instrumente CM -Instrumente CM ERISOPHAKE CM TUNING FORK CM -Instrumente CM UROLOGICAL BOUGIE CM -Instrumente CM -Instrumente CM VAGINAL RETRACTOR CM AC POWERED CAST CM -Instrumente CM OPHTHALMIC RETRACTOR CM -Instrumente CM SURGICAL SPATULA CM -Instrumente CM NON-POWERED RECTAL PROBE CM -Instrumente CM RUBBER DAM AND ACCESSORIES CM -Instrumente CM ORTHOPEDIC KNIFE CM -Instrumente CM -Instrumente CM SURGICAL RAZOR CM -Instrumente CM -Instrumente CM FLEXIBLE DIAGNOSTIC FRESNEL LENS CM NASAL SAW CM -Instrumente CM TONGUE DEPRESSOR CM -Instrumente CM CORNEO-SCLERAL PUNCH CM -Instrumente CM SKULL PUNCH CM -Instrumente CM ADENOID CURETTE CM -Instrumente CM MANUAL STETHOSCOPE CM -Instrumente CM EAR SCISSORS CM -Instrumente CM -Instrumente CM -Instrumente REAMER CM TONSIL DISSECTOR CM -Instrumente CM -Instrumente CM OPHTHALMIC TREPHINE CM TRACHEAL HOOK CM -Instrumente PROSTHESIS CM -Instrumente CM ORTHOPEDIC PASSER WIRE CM -Instrumente STARTER BONE SCREW CM -Instrumente CM -Instrumente CM NASAL SNARE CM -Instrumente CM DENTAL SCISSORS CM SOCKET POSITIONER CM -Instrumente CM -Instrumente CM EYELID CLAMP CM DEPTH GAUGE CM -Instrumente CM -Instrumente CM SURGICAL METAL TONGUE DEPRESSOR RETENTIVE AND SPLINTING PIN AND ACCESSORY INSTRUMENTS CM -Instrumente CM SURGICAL STAPLER CM -Instrumente CM CATHETERS CM -Instrumente STAPLE DRIVER CM -Instrumente CM -Instrumente CM EPISIOTOMY SCISSORS COMPRESSION CM -Instrumente CM LACHRYMAL PROBE CM -Instrumente CM non-electrical clamp CM -Instrumente CM -Instrumente CM SURGICAL MALLET CM -Instrumente CM NON-STERILE IRRIGATING SYRINGE CM -Instrumente CM SURGICAL TRAY CM -Instrumente CM TRACHEAL TUBE FIXATION CM -Instrumente CM WIRE CUTTER CM -Instrumente CM -Instrumente CM Instrumente PIN CM -Instrumente CM NASAL CURETTE CM -Instrumente CM -Instrumente CM OPHTHALMIC MIRROR HEADBAND SUGICAL NEURO INSTRUMENT CM -Instrumente CM BONE TAP CM -Instrumente SKIN PRESSURE PROTECTOR CM -Instrumente CM LACHRYMAL DILATOR CM -Instrumente CM -Instrumente CM OPHTHALMIC CALIPER CM NASAL INHALER CM -Instrumente

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2006-08-11
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-11
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2006-08-11
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 2006-08-11
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2006-08-16
HXC Wrench Orthopedic Class 1 888.4540 2007-07-26
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2006-08-11
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2006-08-11
JXX Forceps, Wire Closure, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2006-08-11
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2007-07-26
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2006-08-11
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2008-10-23
HWB Extractor Orthopedic Class 1 888.4540 2007-07-26
FNS Ring Cutter General Hospital Class 1 880.6200 2006-08-11
HXS Twister, Wire Orthopedic Class 1 888.4540 2006-08-11
HNT Erisophake Ophthalmic Class 1 886.4350 2006-08-11
HTD Forceps General, Plastic Surgery Class 1 878.4800 1994-02-09
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2006-08-11
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2006-08-11
GWX Fork, Tuning Neurology Class 1 882.1525 2006-08-11
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2006-08-11
EMI File, Bone, Surgical Dental Class 1 872.4565 2006-08-11
GWY Pinwheel Neurology Class 1 882.1750 2006-08-11
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2006-08-11
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2006-08-11
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2006-08-11
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2006-08-11
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2006-08-11
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-11
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 2006-08-11
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2006-08-11
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 2006-08-11
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2006-08-11
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2007-07-26
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2006-08-11
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2006-08-11
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
HJJ Lens, Fresnel, Flexible, Diagnostic Ophthalmic Class 1 886.1390 2006-08-11
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2006-08-11
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2006-08-11
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2006-08-11
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2006-08-11
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2006-08-11
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-11
GXJ Punch, Skull Neurology Class 1 882.4750 2006-08-11
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2006-08-11
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2016-03-04
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2006-08-11
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2006-08-11
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2006-08-11
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2007-07-26
HTO Reamer Orthopedic Class 1 888.4540 2007-07-26
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2006-08-11
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2006-08-11
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2007-07-26
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2006-08-11
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2007-07-26
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2006-08-11
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2006-08-11
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2006-08-11
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-11
HTR Rasp General, Plastic Surgery Class 1 878.4800 2006-08-11
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2006-08-11
KIL Positioner, Socket Orthopedic Class 1 888.4540 2006-08-11
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2006-08-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2006-08-11
FNY Basin, Emesis General Hospital Class 1 880.6730 2006-08-11
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2006-08-11
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2007-07-26
GAG Stapler, Surgical General Hospital Class 2 878.4740 2006-08-11
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2006-08-11
HXJ Staple Driver Orthopedic Class 1 888.4540 2007-07-26
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2006-08-11
HWN Instrument, Compression Orthopedic Class 1 888.4540 2007-07-26
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2006-08-11
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2010-03-18
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-11
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 1994-02-09
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-07-26
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2006-08-11
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2006-08-11
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2006-08-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-08-11
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-02-09
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2006-08-11
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2006-08-11
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1994-02-09
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2007-07-26
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2006-08-11
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2006-08-11
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2006-08-16
HWX Tap, Bone Orthopedic Class 1 888.4540 2006-08-11
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2007-07-26
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2006-08-11
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2006-08-11
GAD Retractor General, Plastic Surgery Class 1 878.4800 1994-03-17
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2006-08-11

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

CM 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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06
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
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009 Becton Dickinson and Company 1
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0070-2019 COVIDIEN LLC 2
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

Similar Registrations

Registration Number Establishment Name Location
3010155661 Synergy Health Sterilisation UK Ltd Thorne Doncaster, GB
3010455030 ENDO TECH INSTRUMENTS Sialkot Punjab, PK
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
3010829427 SWANTIA MEDICAL PRIVATE LIMITED Sialkot Punjab, PK
2916714 AESCULAP, INC. CENTER VALLEY, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680518. Last updated year: 2026. Please use registration number 9680518 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.