Medical Device Manufacturer · US , Mchenry , IL

Unitron Industries, Inc.

69 submissions · 69 cleared · Since 1976
69
Total
69
Cleared
0
Denied

Unitron Industries, Inc. — FDA 510(k) Submissions

Unitron Industries, Inc. has submitted 69 FDA 510(k) premarket notifications since 1976, of which 69 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription . Use the specialty filter in the sidebar to narrow results.

69 devices
1–25 of 69
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1997 24d
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1997 24d
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1997 24d
UNITRON MODEL SOUND F/X CIC
K970692 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1997 72d
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1997 72d
UNITRON MODEL SOUND F/XP +4
K964502 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL SOUND F/X +4
K964503 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL ICON AOHPL +4
K964504 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
K964508 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 19d
UNITRON MODEL ICON KR
K963122 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1996 25d
UNITRON MODEL SOUND F/XP
K960155 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1996 56d
UNITRON MODEL IKON AOHPD
K953727 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1995 58d
UNITRON MODEL SOUND F/XD
K953932 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1995 61d
UNITRON MODEL SOUND F/X II
K954516 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1995 9d
UNITRON MODEL SOUND F/X
K954430 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1995 14d
UNITRON MODEL IKON AOHPL
K953646 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 24d
UNITRON MODEL ESTEEM
K950759 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 42d
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1995 32d
UNITRON MODEL SOUNG F/S
K946264 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1995 34d
AIR CONDUCTION HEARING AID
K944520 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1994 102d
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
K935867 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1994 106d
AIR CONDUCTION HEARING AID: IKON PP
K936106 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1994 89d
UNITRON MODEL IKON AGCO/ AOD
K934565 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1993 74d
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