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Gb Implantat Technologie, Essen, Germany – FDA Inspections

Inspection records and compliance data for Gb Implantat Technologie in Essen. 3 FDA inspections on record, 2 Form 483s, last inspected August 21, 2025.

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Company Profile

This profile covers Gb Implantat Technologie based in Essen, Germany.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
2
Warning letters
0

First inspected February 11, 2015. Last inspected August 21, 2025.

Most cited issue areas

  • Equipment control activity documentation1 inspection
  • Lack of or inadequate procedures1 inspection
  • Nonconforming product, Lack of or inadequate procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
August 21, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1279033
August 16, 2018VAIMedical Devices & Rad Health · Compliance: Devices1071168
February 11, 2015NAIMedical Devices & Rad Health · Compliance: Devices914433
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Normed Medizin-Technik, GmbH
Biocer Entwicklungs, GMBH
GELITA DEUTSCHLAND GMBH
Teleflex Medical Gmbh
Nicolay GmbH
Company Information

Name

Gb Implantat Technologie

FEI Number

3000258338

Address

Harkortstr. 65, Essen, Germany

Country

Germany

ID: b0b19567-8554-4140-9626-b87d39b80f26

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