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The Synaptic Corp.

Aurora, CO, US

The Synaptic Corp. appears in FDA device records in Aurora, CO. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for The Synaptic Corp. in 1997.

Clearances by year, as a table
510(k) clearance decisions for The Synaptic Corp., by decision year
YearClearances
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K940954SYNAPTIC 3000GZJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1440-2012Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other medical treatment uses.Device was distributed without marketing approval.Terminated

Verification record

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