510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HOBClass I

Clamp, Muscle, Ophthalmic

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HOB is the FDA product code for Clamp, Muscle, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HOB
Device name
Clamp, Muscle, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code HOB

By decision year
3 clearances under product code HOB with a decision year between 1978 and 1984, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HOB by decision year
YearClearances
19781
19842

Applicants with the most clearances

Product code HOB
Applicants holding the most 510(k) clearances under product code HOB
ApplicantClearances
Imm Enterprises, Ltd.1
Truline Instruments, Inc.1
Varian Assoc., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order