Fetzer Medical GmbH & Co. KG

FDA Regulatory Profile

Fetzer Medical GmbH & Co. KG appears in FDA public data with 4 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0758-2019, Class II) was initiated on December 28, 2018. Its most recent 510(k) clearance was granted on May 8, 2018.

Summary

Total Recalls
4
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0758-2019Class II12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 December 28, 2018
Z-0755-2019Class II16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 FDecember 28, 2018
Z-0757-2019Class II16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 FetzDecember 28, 2018
Z-0756-2019Class II12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 December 28, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K172661Fetzer Medical Gynecological ForcepsMay 8, 2018
K163524Vessel DilatorJune 29, 2017
K161004Self-retaining RetractorSeptember 9, 2016