Medical Device Manufacturer · US , Mchenry , IL

Rexton, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1983
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Rexton, Inc. Ear, Nose, Throat

21 devices
1-21 of 21
Cleared Mar 28, 1997
REXTON MODEL 48 AND 49PP
K970537 · ESD
Ear, Nose, Throat · 44d
Cleared Nov 27, 1996
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K964451 · ESD
Ear, Nose, Throat · 21d
Cleared Mar 22, 1996
LONG LIFE RX-12
K960295 · ESD
Ear, Nose, Throat · 60d
Cleared Jan 17, 1996
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE...
K954922 · ESD
Ear, Nose, Throat · 83d
Cleared Sep 18, 1995
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
K953770 · ESD
Ear, Nose, Throat · 35d
Cleared Mar 21, 1995
M-29 PP-PC, M-29 PP-O/PC
K950451 · ESD
Ear, Nose, Throat · 46d
Cleared Feb 22, 1995
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
K944851 · ESD
Ear, Nose, Throat · 145d
Cleared Dec 30, 1994
ORION PPM, PP, PP-D
K944777 · ESD
Ear, Nose, Throat · 94d
Cleared Dec 29, 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
K944359 · ESD
Ear, Nose, Throat · 113d
Cleared Dec 21, 1994
DEEP CANAL HEARING INSTRUMENT
K942702 · ESD
Ear, Nose, Throat · 196d
Cleared Nov 14, 1994
REXPLUS PP3
K944548 · ESD
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
K915683 · ESD
Ear, Nose, Throat · 21d
Cleared Jan 09, 1992
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
K915684 · ESD
Ear, Nose, Throat · 21d
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341 · ESD
Ear, Nose, Throat · 127d
Cleared Mar 27, 1990
REXTON PP 142, PP 142-L
K900636 · ESD
Ear, Nose, Throat · 46d
Cleared Jan 16, 1990
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
K896057 · ESD
Ear, Nose, Throat · 90d
Cleared Jan 10, 1990
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
K896056 · ESD
Ear, Nose, Throat · 84d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898 · ESD
Ear, Nose, Throat · 110d
Cleared May 19, 1989
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
K892333 · ESD
Ear, Nose, Throat · 44d
Cleared Jun 05, 1986
RX-33S INTRA MINI CANAL MODULE
K861532 · ESD
Ear, Nose, Throat · 42d
Cleared Sep 29, 1983
REXTON RX10, RX20-30 & 40
K832180 · ESD
Ear, Nose, Throat · 85d
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