510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HWNClass I

Instrument, Compression

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

HWN is the FDA product code for Instrument, Compression, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
HWN
Device name
Instrument, Compression
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
9

Clearances, product code HWN

By decision year
4 clearances under product code HWN with a decision year between 1976 and 1986, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HWN by decision year
YearClearances
19761
19771
19791
19861

Applicants with the most clearances

Product code HWN
Applicants holding the most 510(k) clearances under product code HWN
ApplicantClearances
Advanced Ortho-Technology, Inc.1
Richard Wolf Medical Instruments Corp.1
Richard'S Medical Equip., Inc.1
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 155 companies shown, in name order