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

Dk 2820 Gentofte, DK

B & K Medical A/S appears in FDA device records in Dk 2820 Gentofte, DK. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for B & K Medical A/S between 1981 and 2000. The busiest year on record is 1994, with 2. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for B & K Medical A/S, by decision year
YearClearances
19811
19942
19951
19961
19991
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K002085ULTRASOUND SCANNER, TYPE 1101IYOSubstantially Equivalent
K000567ULTRASOUND SCANNER TYPE 2102IYOSubstantially Equivalent
K991937ULTRASOUND SCANNER, MODEL TYPE 2101IYOSubstantially Equivalent
K943315ULTRASOUND SCANNER 2002IYOSubstantially Equivalent
K936024ULTRASOUND SCANNER 2001IYOSubstantially Equivalent
K926332DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIEDIYOSubstantially Equivalent
K933056DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIEDIYOSubstantially Equivalent
K802878K-KATH URETHRAL CATHETER INTRODUCERKODSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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

MDM coverage

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