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•United States

SpectraWAVE, Inc., Bedford, MA – FDA Inspections

Inspection records and compliance data for SpectraWAVE, Inc. in Bedford, MA. 1 FDA inspection on record, 1 Form 483, last inspected August 11, 2026.

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Company Profile

This profile covers SpectraWAVE, Inc. based in Bedford, MA, United States.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
0
NAI
0
Unclassified
1
Form 483s
1
Warning letters
0

Inspected August 11, 2026.

Most cited issue areas

  • Complaint handling procedures not documented1 inspection
  • Corrective action procedures not documented1 inspection
  • Failure to submit, distinct marking1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 11, 2026Not classifiedMedical Devices & Rad Health · Radiation Control and Health Safety Act1330484
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

SpectraWAVE, Inc.

FEI Number

3017654247

Address

12 Oak Park Dr, Bedford, MA 01730-1443, United States

Country

United States

ID: dc6e5734-f26f-4562-a09d-715ca06b14c2

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