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

Mahwah, NJ, US

Dantec Medical, Inc. appears in FDA device records in Mahwah, NJ. FDA records list 25 510(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
25
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 25 510(k) clearances for Dantec Medical, Inc. between 1990 and 1996. The busiest year on record is 1990, with 4. The most recent is 1996, with 2.

Clearances by year, as a table
510(k) clearance decisions for Dantec Medical, Inc., by decision year
YearClearances
19904
19914
19924
19934
19943
19954
19962
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K960503DANTEC DUETFENSubstantially Equivalent
K950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)GXZSubstantially Equivalent
K953999DANTEC DA CAPOEXYSubstantially Equivalent
K926363MULTI-DOP SIYOSubstantially Equivalent
K931801MULTI-DOP XIYOSubstantially Equivalent
K930458MULTI-DOP LIYNSubstantially Equivalent
K932059NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODEIKTSubstantially Equivalent
K934580DANTEC 13R45 BAR ELECTRODEGXYSubstantially Equivalent
K931966DANTEC DISPOSABLE CONCENTRIC NEEDLEIKTSubstantially Equivalent
K931923DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)GWFSubstantially Equivalent
K926516DANTEC MAGNETIC STIMULATOR MAGPROGWFSubstantially Equivalent
K924127DANTEC EVOLUTIONGWFSubstantially Equivalent
K923117CAVERNOSOMETRY MODULE FOR MENUETDXTSubstantially Equivalent
K915741DISPOSABLE MONOPLAR MEDDLE ELECTRODESGXESubstantially Equivalent
K913957DANTEC COUNTERPOINT MK2(TM)GWJSubstantially Equivalent
K913169DANTEC UD 5500 MK2FAPSubstantially Equivalent
K914891PULLER OPTION FOR ETUDE(TM)FAPSubstantially Equivalent
K912701DANTEC MENUETFAPSubstantially Equivalent
K911229PHOENIX DIGITAL EEG SYSTEMGWQSubstantially Equivalent
K913323ETUDE (MODEL NUMBERS 24A05 & 24A06)FAPSubstantially Equivalent
K902607DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)GWFSubstantially Equivalent
K901494ETUDE, URODYNAMIC INVESTIGATION SYSTEMFAPSubstantially Equivalent
K896874DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12IKTSubstantially Equivalent
K896575DANTEC MENUETFAPSubstantially Equivalent
K896567CANTATA EMG/EVOKED RESPONSE SYSTEMGWFSubstantially 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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Data as of , FDA export datePage updated Source: openFDA, public domain