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

Instrument, Manual, Surgical, General Use

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

MDM is the FDA product code for Instrument, Manual, Surgical, General Use, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 76 recalls.

Classification record

Product code
MDM
Device name
Instrument, Manual, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
44
Ingested recalls
76

Clearances, product code MDM

By decision year
44 clearances under product code MDM with a decision year between 1980 and 2008, 1993 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code MDM by decision year
YearClearances
19801
19811
19861
19901
19913
19928
199312
19947
19951
19981
19991
20012
20022
20052
20081

Applicants with the most clearances

Product code MDM
Applicants holding the most 510(k) clearances under product code MDM
ApplicantClearances
Savoy Medical Supply Co., Inc.4
Falcon Instruments, Inc.3
Acuderm, Inc.2
DeRoyal Industries, Inc.2
American Biomaterials Corp.1
American Safety Razor Co.1
Andrews Surgical Innovations, Ltd.1
Apex Ent., Inc.1
Automated Medical Products Corp.1
Bip USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 771 companies shown, in name order