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

FRIDINGEN Baden-Wurttemberg, DE

RUDOLF MEDICAL GMBH + CO. KG appears in FDA device records in FRIDINGEN Baden-Wurttemberg, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for Rudolf Medical GmbH + Co. KG in 2008.

Clearances by year, as a table
510(k) clearance decisions for Rudolf Medical GmbH + Co. KG, by decision year
YearClearances
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K073498LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEMGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Rudolf Medical GmbH + Co. KG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80102983003448211RUDOLF MEDICAL GMBH + CO. KGZOLLERSTRASSE 1, FRIDINGEN Baden-Wurttemberg 78567 DE2026and 84 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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