510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

Debrecen Hajdu-Bihar, HU

EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT. appears in FDA device records in Debrecen Hajdu-Bihar, HU. 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 EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft. in 2022.

Clearances by year, as a table
510(k) clearance decisions for EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft., by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K213228NeuroLine Disposable Cranial Perforator with Hudson endHBFSubstantially Equivalent

Registered establishments

FDA registered establishments for EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30147245613014724561EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.Bartok Bela Str. 113/B, Debrecen Hajdu-Bihar 4031 HU2026

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