SUBAN Instruments Germany GmbH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010665

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
8010665
FEI Number
1000405819
Entity Name
SUBAN Instruments Germany GmbH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
51 DORNIERSTRASSE, TUTTLINGEN Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SUBAN Instruments Germany GmbH (Owner Number: 8010665)
Owner / Operator Contact Address
DORNIERSTRASSE 51, --, 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

90-6210-02 90-6130

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-06-21
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2013-01-31
EMD Hemostat, Surgical Dental Class 1 872.4565 1992-10-17
HTE Elevator General, Plastic Surgery Class 1 878.4800 2014-07-30
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2013-01-31
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2013-02-12
EIS Remover, Crown Dental Class 1 872.4565 2013-07-08
HDC Tenaculum, Uterine Obstetrics/Gynecology Class 2 884.4530 2012-07-17
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-03-23
EKT Curette, Endodontic Dental Class 1 872.4565 2019-02-14
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2014-07-26
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-31
HBO Clip, Scalp Neurology Class 2 882.4150 2013-02-15
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2013-03-16
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2014-04-23
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1985-06-18
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2014-07-26
HTF Curette General, Plastic Surgery Class 1 878.4800 2013-03-16
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-31
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2014-04-25
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1999-12-17
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-02-11
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2015-11-19
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2012-01-26
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2012-06-19
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-31
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-06-18
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2013-12-05
GWI Discriminator, Two-Point Neurology Class 1 882.1200 2013-07-24
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2019-06-06
EIR Scissors, Collar And Crown Dental Class 1 872.4565 1999-12-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2017-11-14
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-07-26
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 1999-12-27
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2020-02-11
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 1992-10-17
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2014-07-30
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1999-12-27
FFR Device, Locking, For Intestinal Clamp Gastroenterology, Urology Class 1 876.4730 2018-12-20
HWB Extractor Orthopedic Class 1 888.4540 2013-03-16
GAD Retractor General, Plastic Surgery Class 1 878.4800 1999-12-17
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2013-01-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-01
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2005-10-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-11-05
EJY Pliers, Operative Dental Class 1 872.4565 1992-10-21
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2014-07-30
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2013-01-31
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2013-01-31
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2015-02-09
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2013-03-16
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-31
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1999-12-27
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 1999-12-27
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2014-07-30
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 1999-12-27
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2014-07-30
HXW Bender Orthopedic Class 1 888.4540 2013-03-16
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2013-03-16
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2013-01-31
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2014-07-17
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1983-08-29
EIG Retractor, All Types Dental Class 1 872.4565 2019-10-10
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2013-07-08
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 1999-12-27
HXS Twister, Wire Orthopedic Class 1 888.4540 2013-03-16
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2014-07-30
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2005-10-12
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2018-09-06
HWM Osteotome General, Plastic Surgery Class 1 878.4800 1999-12-27
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2013-01-31
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2017-12-07
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-01-31
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-01-31
HXL Mallet General, Plastic Surgery Class 1 878.4800 2017-05-03

Official Correspondent

Zoltan Honvari

US Agent Details

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

Related Public Records

Same Entity

SUBAN Instruments Germany 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
K821275 Conphar, Inc. MAYO SCISSOR STRAIGHT 5 1/2 1982-05-28
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
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

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-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number Establishment Name Location
3014334038 Integra LifeSciences Production Corporation Mansfield, MA, US
8040172 BURAQ SURGICAL CORP. SIALKOT Punjab, PK
9681161 REBSTOCK INSTRUMENTS GMBH DUERBHEIM Baden-Wurttemberg, DE
9611102 RICHARD WOLF GMBH KNITTLINGEN Baden-Wurttemberg, DE
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010665. Last updated year: 2026. Please use registration number 8010665 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.