International Medical Devices Database

Manufacturer Address
Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
Manufacturer Parent Company (2017)
Carl-Zeiss-Stiftung
Source
USFDA
9 Events

9 devices in the database

OPMI VARIO 700 Surgical Microscope

Model / Serial
Serial numbers: 6636101067; 6636101068; 6636101070.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
USA (nationwide) including the states of FL, GA, and LA .
Product Description
OPMI VARIO 700 Surgical Microscope. || Manufactured by: Carl Zeiss Meditec AG, || Oberkochen, Germany. || Provide a magnified view of the surgical field.

OPMI Pentero C

Model / Serial
Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution.
Product Description
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), || Product Usage: || A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

Device Recall INTRABEAM Shielding Material

Model / Serial
Lot 110851; Catalog number 304534-6000-585.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.
Product Description
INTRABEAM Shielding Material Flat 20 x 20 cm, || Sterile/FO || 0.05 mm Pb Equivalent (50keV) || Carl Zeiss Meditec AG || Indicated for radiation therapy treatments.

Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro

Model / Serial
All-OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4, OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA only.
Product Description
OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, || OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4, || OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount. || A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.

INTRABEAM Balloon Applicator Set

Model / Serial
Part number 304534-7500-000; lot number 540958.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including IL and MD
Product Description
INTRABEAM Balloon Applicator Set; || 3.0 cm, || Carl Zeiss Meditec AG, Oberkochen, Germany || INTRABEAM System is intended for radiation therapy treatments

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Carl Zeiss Meditec, Inc.