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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medishield, Inc. — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

12 daysmedian FDA review time
86 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K781103SPECTRASCANMedishield, Inc.1978-09-27860
K780645HMD-2000 BATTERY-POWERED MINI-DRILL, THEMedishield, Inc.1978-05-03160
K780646AIR-PWOERED COLDRILLMedishield, Inc.1978-04-28110
K780202MONOMER EVACUATION SYSTEMMedishield, Inc.1978-02-21140
K770161MICROFENESTRATED HIP REPLACEMENT COMPON.Medishield, Inc.1977-01-2620
K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)Medishield, Inc.1976-11-23120
K761020ANKLE (FREEMAN-SWANSON)Medishield, Inc.1976-11-23120
K760668SELECTATEC SYSTEMMedishield, Inc.1976-09-27100

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda