FETZER MEDICAL GMBH & CO.KG

FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 3007648354

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
3007648354
FEI Number
3007648354
Entity Name
FETZER MEDICAL GMBH & CO.KG
City/State/Country
Tuttlingen Baden-Wurttemberg, DE
Establishment Address
Unter Buchsteig 5, Tuttlingen Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Fetzer Medical GmbH & Co.KG (Owner Number: 10029400)
Owner / Operator Contact Address
Unter Buchsteig 5, 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

removal hook Adenoid Curette nasal rasp McGivney Haemorrhoidal Ligator Retractor - Peek retractor wire tightener wire twister rongeur chisel ophthalmic hook Hammer Bone Mallet mobilizer Carter Sphere Introducer snare wire coil Rongeur tonsil scissors sinus scissors forceps uterine sound wire cutter trephine mallet hammer Suction Irrigator Tuning Fork ruler scissors caliper Root Tip Pick graft packer Oral Root Teaser uterine scoop Common Duct Scoop gall stone scoop Endodontic Curette IVD Rongeurs Laminectomy Rongeurs Kerrison Rongeurs Root Elevator file eyelid clamp perforating drill dilator ear snare burr probe Calliper Diamond Knife Keratome clamp speculum reamer Spud and Gouge foreign body spud catheter forceps Intubation forceps curette depth gauge Plate Bending Iron Rod Bender Bending Plier scalpel handle lacrimal dilator Amputation Knife stripper McCulloch Type Retractor Weitlaner Retractors Meyerding Retractors McBride Retractors Wiltse-Gelpi Retractor Scoville Hemilaminectomie Retractors arkham Meyerding Retractors, Cloward Style Cervical Retractor, M-Style Retractors Spinal Discectomy Retractors, Darling Popliteal Retractors, MIS Tubular Retractor Ducker Retractors Fetzer Medical Self-retaining Retractors clamp tray Bone Chisel forceps osteotome micro scissors spatula probe chisel tracheal retractor episiotomy scissors ENT retractor Debakey Vascular Dilator Cooley Vessel Dilator Cooley Dilator Myocardial Dilator Hiebert Vascular Dilator Sarns Dilator Garrett Vascular Dilator Total Ankle, Instrument, Trial Talus Lollipop Pliers bone hook Umbilical scissors punch impactor suction tube chisel uterine curette elevator hook Tongue Depressor degree ring Periodental probe ENT mirror osteotome extracting forceps SF Push-in Anchor 2.3 hook knife spatula screwdriver Elevator osteotome speculum Nasal Chisel vascular clamps Clip Applier Awl urethrotome Tournique applicator Ligature carrier Uterine Biopsy Forceps Biopsy Punch Ethmoid curette mouth gag needle holder Adapter Cannula injection needle Dissector biopsy forceps ligature needle needle ophthalmic scissor Guiding Probe speculum Cystotome vein strippers nasal snare cannula gigli saw periodontal curette lid retractor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2016-03-08
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2017-05-18
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2014-02-28
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2018-06-19
GAD Retractor General, Plastic Surgery Class 1 878.4800 2010-05-04
HXS Twister, Wire Orthopedic Class 1 888.4540 2015-02-05
HTX Rongeur Orthopedic Class 1 888.4540 2013-02-19
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2014-10-17
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2011-07-12
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2016-03-08
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 2014-10-17
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 2017-09-06
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2013-02-19
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2010-05-04
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2016-03-08
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-07-07
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2013-02-19
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-02-19
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2014-10-17
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-19
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2014-07-25
GWX Fork, Tuning Neurology Class 1 882.1525 2014-07-25
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2010-08-05
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2009-05-20
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2010-03-08
DZN Instruments, Dental Hand Dental Class 1 872.4565 2016-03-08
FHL Scoop Gastroenterology, Urology Class 1 876.4730 2016-01-22
EKT Curette, Endodontic Dental Class 1 872.4565 2014-07-25
HAE Rongeur, Manual Neurology Class 2 882.4840 2016-03-08
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2015-06-19
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-18
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2014-02-28
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2016-03-08
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2013-02-19
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-02-19
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 2014-10-17
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2015-06-08
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2013-02-19
HXB Probe Orthopedic Class 1 888.4540 2013-02-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2014-07-25
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2014-07-25
HXD Clamp General, Plastic Surgery Class 1 878.4800 2011-05-12
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2013-02-19
HTO Reamer Orthopedic Class 1 888.4540 2013-10-23
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2014-10-17
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2016-03-08
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2013-02-18
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2014-02-28
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2014-07-25
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2013-02-18
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2013-02-19
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2011-07-12
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2014-10-17
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2016-09-12
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-03-19
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2013-02-18
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2011-07-20
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2014-06-17
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-19
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-02-19
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2011-07-20
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-18
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2013-02-19
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-02-19
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2013-02-19
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2013-02-19
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2016-03-08
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2014-02-28
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2017-07-03
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2023-11-29
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2014-02-14
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2014-03-27
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2016-03-08
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2010-03-08
HWA Impactor Orthopedic Class 1 888.4540 2011-07-12
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2010-03-19
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2013-02-18
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2013-02-19
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-18
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-18
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2025-08-06
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2014-02-28
EIX Probe, Periodontic Dental Class 1 872.4565 2015-01-23
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2014-02-28
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2011-07-20
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2015-06-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-05-25
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2013-02-19
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2013-02-19
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-19
HXX Screwdriver Orthopedic Class 1 888.4540 2011-11-29
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-18
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2015-06-19
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2011-07-12
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2014-06-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-05-16
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2014-07-25
HWJ Awl Orthopedic Class 1 888.4540 2014-07-25
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2016-03-08
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2015-02-05
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2016-03-08
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2014-06-17
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2014-07-25
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2017-05-18
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2013-02-19
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2010-05-04
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2014-06-17
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2016-03-08
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-18
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2016-01-22
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2013-03-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-10-27
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-18
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-07-25
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2012-10-24
HNY Cystotome Ophthalmic Class 1 886.4350 2014-07-25
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2016-03-08
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-19
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-18
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2013-02-19
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2015-06-19
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

Max Fetzer Business: Fetzer Surgical LLC. Email: max@fetzersurgical.com Phone: (602) 8057005

Related Public Records

Same Entity

Fetzer Medical GmbH & Co.KG
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
K000397 Boston Scientific Corp SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL 2000-03-07
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K894785 Fdt Precision Machine Co., Inc. SURGICAL CHISEL/OSTEOTOME 1989-08-18

Related Recall Records

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007648354. Last updated year: 2026. Please use registration number 3007648354 when referencing this establishment in official correspondence.
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