EXACT MEDICAL MANUFACTURING, INC.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Counter, Sponge, SurgicalProduct code LWH (opens in a new tab) · Class I · General Hospital · 21 CFR 880.2740
Recalls & enforcement
- Class IITerminated2021-04-29No 510k for the product to be used in a natural or surgical opening to the body
FDA inspections (1)
- NAI2019-05-02No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “EXACT MEDICAL MANUFACTURING, INC. (FEI 3013443304) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013443304-exact-medical-manufacturing-inc/
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