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

Heiligenhaus North Rhine-Westphalia, DE

HIDREX GMBH appears in FDA device records in Heiligenhaus North Rhine-Westphalia, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 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
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Hidrex GmbH in 2015.

Clearances by year, as a table
510(k) clearance decisions for Hidrex GmbH, by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K133033HIDREX PSP1000EGJSubstantially Equivalent

Registered establishments

FDA registered establishments for Hidrex GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30086429823008642982HIDREX GMBHOtto-Hahn-Str. 12, Heiligenhaus North Rhine-Westphalia 42579 DE2026

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-1238-2017Daavlin Aquex (DAAV1000)The device was reclassified from a class III device to a class II device and there are new documentation requirements.Class IIITerminated
Z-1237-2017Hidrex USA DVP1000The device was reclassified from a class III device to a class II device and there are new documentation requirements.Class IIITerminated
Z-1236-2017Hidrex USA DP450The device was reclassified from a class III device to a class II device and there are new documentation requirements.Class IIITerminated

Verification record

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