VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG

FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 8010349

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
8010349
FEI Number
3000219468
Entity Name
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG
City/State/Country
Tuttlingen Baden-Wurttemberg, DE
Establishment Address
In Goehren 25, Tuttlingen Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
VOMED Volzer Medizintechnik GmbH & Co.KG (Owner Number: 10092168)
Owner / Operator Contact Address
In Goehren 25, 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

LUER-Lock Schlauchverbinder LUER-Lock Schlauchverbinder Obturator Cannula Male Luer-cone Connector LUER-Lock Schlauchverbinder Adaptor for TOOMEY Syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-01-15
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2024-12-17
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2024-12-18
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-11
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2024-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-12-17

Official Correspondent

Steven Suske

US Agent Details

Anja Fair Business: Karl Storz Email: Anja.Fair@karlstorz.com Phone: (424) 2188247

Related Public Records

Same Entity

VOMED Volzer Medizintechnik 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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010349. Last updated year: 2026. Please use registration number 8010349 when referencing this establishment in official correspondence.
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