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

Waechtersbach Hesse, DE

SFM Medical Devices GmbH appears in FDA device records in Waechtersbach Hesse, DE. FDA records list 3 510(k) clearances between and , 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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for SFM Medical Devices GmbH between 2019 and 2024. The busiest year on record is 2024, with 2. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for SFM Medical Devices GmbH, by decision year
YearClearances
20191
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241976nextaro® va, 15mm, 5µmLHISubstantially Equivalent
K240748nextaro® v, 20/20LHISubstantially Equivalent
K183187nextaro Transfer System, nextaro vaLHISubstantially Equivalent

Registered establishments

FDA registered establishments for SFM Medical Devices GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10006328571000632857SFM Medical Devices GmbHBrueckenstrasse 5, Waechtersbach Hesse 63607 DE2026and 1 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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Data as of , FDA export datePage updated Source: openFDA, public domain