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

Binder, Medical, Therapeutic

21 CFR 880.5160 / General Hospital
FDA source (opens on fda.gov)

MDR is the FDA product code for Binder, Medical, Therapeutic, a class I device type, regulated under 21 CFR 880.5160. As of , FDA records hold no 510(k) clearances under this code and 19 recalls.

Classification record

Product code
MDR
Device name
Binder, Medical, Therapeutic
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
19

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 67 companies shown, in name order