510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Fetzer Medical GmbH & Co.KG

Tuttlingen Baden-Wurttemberg, DE

FETZER MEDICAL GMBH & CO.KG appears in FDA device records in Tuttlingen Baden-Wurttemberg, DE. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Fetzer Medical GmbH & Co.KG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Fetzer Medical GmbH & Co. KG510(k), enforcement report, recall

510(k) clearance history

FDA records hold 3 510(k) clearances for Fetzer Medical GmbH & Co.KG between 2016 and 2018. The busiest year on record is 2016, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Fetzer Medical GmbH & Co.KG, by decision year
YearClearances
20161
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K172661Fetzer Medical Gynecological ForcepsHCZSubstantially Equivalent
K163524Vessel DilatorDWPSubstantially Equivalent
K161004Self-retaining RetractorGZTSubstantially Equivalent

Registered establishments

FDA registered establishments for Fetzer Medical GmbH & Co.KG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076483543007648354FETZER MEDICAL GMBH & CO.KGUnter Buchsteig 5, Tuttlingen Baden-Wurttemberg 78532 DE2026and 154 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0758-201912002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.The firm had a report of doctors being unable to pull the obstetric forceps apart.Class IITerminated
Z-0757-201916600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.The firm had a report of doctors being unable to pull the obstetric forceps apart.Class IITerminated
Z-0756-201912002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.The firm had a report of doctors being unable to pull the obstetric forceps apart.Class IITerminated
Z-0755-201916600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.The firm had a report of doctors being unable to pull the obstetric forceps apart.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain