Baxter Medical Systems GmbH + Co. KG

FDA Device Registration & Listing · Munich Bavaria, DE · Registration 9681407

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
9681407
FEI Number
1000182014
Entity Name
Baxter Medical Systems GmbH + Co. KG
City/State/Country
Munich Bavaria, DE
Establishment Address
Landsberger Str. 155, Munich Bavaria 80687, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)
Owner / Operator Contact Address
One Baxter Parkway, Deerfield, IL 60015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surgical Light (TruLight 5000/3000) and accessories [Baxter] Surgical Light (TruLight 5000/3000) and accessories [Baxter] Surgical Light (TruLight 5000/3000) and accessories [Baxter] OR Camera (TruVidia HD, 4K Camera, 4K Refreshing Unit) and accessories [Baxter] Surgical Light (TruLight 5000/3000, Helux Pro) and accessories [Baxter] TruLight 1000 Examination Light and accessories [Baxter] Green Series Exam Lights (Light IV, 300, 600, 900) and Accessories [a Welch Allyn, Inc. Tijuana Product] Surgical Light System (TruLight 3000, TruLight 5000) and accessories [Baxter]

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2022-01-10
FSQ Light, Surgical, Instrument General, Plastic Surgery Class 2 878.4580 2022-01-10
FSS Light, Surgical, Floor Standing General, Plastic Surgery Class 2 878.4580 2022-01-10
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2022-01-10
FQP Lamp, Operating-Room General, Plastic Surgery Class 2 878.4580 2022-01-10
KZF Device, Medical Examination, Ac Powered General Hospital Class 1 880.6320 2022-01-10
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2022-01-10

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014226707 BARDY DIAGNOSTICS, INC. Bellevue, WA, US
3019257308 VIDEOMED SRL LIMENA Padova, IT
1314492 Baxter Healthcare Corporation MEDINA, NY, US
3007143268 Baxter Medical Systems GmbH + Co. KG SAALFELD Thuringia, DE
8010130 BAXTER SA LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K851742 Burton Medical Products Corp. MEDICAL EXAMINATION LIGHTS 1985-05-13
K780666 Castle Co. DAYSTAR SELECTRA & SELECTRA/ORBITER 1978-04-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681407. Last updated year: 2026. Please use registration number 9681407 when referencing this establishment in official correspondence.
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