Company ยท US
Unitron Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1997. Name variants (Inc, Corp, punctuation) are merged.
69510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 69 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 1997 | K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE Unitron Industries, Inc. | ESD |
| Dec 12, 1997 | K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE Unitron Industries, Inc. | ESD |
| Dec 12, 1997 | K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) Unitron Industries, Inc. | ESD |
| May 8, 1997 | K970692 | UNITRON MODEL SOUND F/X CIC Unitron Industries, Inc. | ESD |
| Apr 24, 1997 | K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964504 | UNITRON MODEL ICON AOHPL +4 Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964503 | UNITRON MODEL SOUND F/X +4 Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964502 | UNITRON MODEL SOUND F/XP +4 Unitron Industries, Inc. | ESD |
| Sep 6, 1996 | K963122 | UNITRON MODEL ICON KR Unitron Industries, Inc. | ESD |
| Mar 7, 1996 | K960155 | UNITRON MODEL SOUND F/XP Unitron Industries, Inc. | ESD |
| Oct 7, 1995 | K954516 | UNITRON MODEL SOUND F/X II Unitron Industries, Inc. | ESD |
| Oct 7, 1995 | K953932 | UNITRON MODEL SOUND F/XD Unitron Industries, Inc. | ESD |
| Oct 7, 1995 | K953727 | UNITRON MODEL IKON AOHPD Unitron Industries, Inc. | ESD |
| Oct 6, 1995 | K954430 | UNITRON MODEL SOUND F/X Unitron Industries, Inc. | ESD |
| Aug 28, 1995 | K953646 | UNITRON MODEL IKON AOHPL Unitron Industries, Inc. | ESD |
| Mar 31, 1995 | K950759 | UNITRON MODEL ESTEEM Unitron Industries, Inc. | ESD |
| Jan 30, 1995 | K946323 | UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID Unitron Industries, Inc. | ESD |
| Jan 26, 1995 | K946264 | UNITRON MODEL SOUNG F/S Unitron Industries, Inc. | ESD |
| Dec 27, 1994 | K944520 | AIR CONDUCTION HEARING AID Unitron Industries, Inc. | ESD |
| Mar 22, 1994 | K935867 | AIR CONDUCTION HEARING AID, UNITRON IKON K & KD Unitron Industries, Inc. | ESD |
| Mar 21, 1994 | K936106 | AIR CONDUCTION HEARING AID: IKON PP Unitron Industries, Inc. | ESD |
| Nov 29, 1993 | K934565 | UNITRON MODEL IKON AGCO/ AOD Unitron Industries, Inc. | ESD |
| Nov 19, 1993 | K934586 | PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID Unitron Industries, Inc. | ESD |
| Feb 8, 1993 | K925600 | VISTA 4000 SIGMA Unitron Industries, Inc. | ESD |
| Nov 5, 1991 | K914689 | HEARING AID, UNITRON MODEL VISTA 4000 Unitron Industries, Inc. | ESD |
| Nov 5, 1991 | K914688 | HEARING AID, UNITRON MODEL VISTA 3000 Unitron Industries, Inc. | ESD |
| Jul 31, 1991 | K912870 | HEARING AID, UNITRON MODEL UIK Unitron Industries, Inc. | ESD |
| Dec 7, 1990 | K904576 | HEARING AID, UNITRON MODEL UM60-UH Unitron Industries, Inc. | ESD |
| Apr 18, 1990 | K901569 | BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL Unitron Industries, Inc. | ESD |
| Jan 3, 1989 | K884288 | HEARING AID, UNITRON BTE MODEL UM60-AGC0 Unitron Industries, Inc. | ESD |
| Sep 1, 1988 | K883513 | HEARING AID, UNITRON MODEL VISTA 1000 Unitron Industries, Inc. | ESD |
| Aug 9, 1988 | K882375 | HEARING AID, UNITRON MODEL UI5 Unitron Industries, Inc. | ESD |
| Mar 11, 1987 | K870503 | HEARING AID, UNITRON MODEL UM60 Unitron Industries, Inc. | ESD |
| Oct 24, 1986 | K863225 | UNITRON MODEL UL21 HEARING AID Unitron Industries, Inc. | ESD |
| Jul 31, 1986 | K862760 | HEARING AID, UNITRON MODEL UF11 Unitron Industries, Inc. | ESD |
| Nov 7, 1985 | K853781 | UNITRON MODEL UM60-PP Unitron Industries, Inc. | ESD |
| Nov 7, 1985 | K853780 | UNITRON MODEL UM60-D Unitron Industries, Inc. | ESD |
| Jul 31, 1985 | K852690 | HEARING AID, UNITRON MODEL UM60-H Unitron Industries, Inc. | ESD |
| Jun 5, 1985 | K850914 | HEARING AID, UNITRON MODEL UC Unitron Industries, Inc. | ESD |
| Jan 23, 1985 | K843246 | HEARING AID, UNITRON UE12-PPL Unitron Industries, Inc. | ESD |
| Jan 10, 1985 | K843245 | HEARING AID, UNITRON UE12-PP Unitron Industries, Inc. | ESD |
| Mar 30, 1984 | K840842 | HEARING AID UNITRON UE8 Unitron Industries, Inc. | ESD |
| Nov 21, 1983 | K833615 | HEARING AID UNITRON UI3 Unitron Industries, Inc. | ESD |
| Nov 21, 1983 | K833614 | HEARING AID, UNITRON UT1 Unitron Industries, Inc. | ESD |
| Aug 12, 1983 | K831883 | HEARING AID UNITRON #UE8-D Unitron Industries, Inc. | ESD |
| Mar 7, 1983 | K830402 | HEARING AID, #UE7-D Unitron Industries, Inc. | ESD |
| Dec 28, 1982 | K823669 | HEARING AID UNITRON #UE4-H Unitron Industries, Inc. | ESD |
Newest 50 of 69.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||