Atlas FDA

HWB

5 FDA 510(k) clearances · Product code

10 daysmedian time to decision
49 days90th percentile
5clearances measured

FDA profile

Official device name
Extractor
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
Adverse events (MAUDE)
2021: 322 · 2022: 319 · 2023: 349 · 2024: 285 · 2025: 291 · 2026: 150
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 (K873710)Arthropedics, Inc.1987-11-02
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR (K870844)Warsaw Orthopedic, Inc.1987-03-13
FERRAY EXTRACTOR (K870083)Terray Manufacturing, Inc.1987-02-26
THE EXTRACTOR I TM (K801327)The Anspach Effort, Inc.1980-06-09
HIP PLATE REMOVAL INSTRUMENT (K780300)Richard'S Medical Equip., Inc.1978-02-28

Track HWB automatically

Every clearance here is in the API, with alerts when new ones post.