Medical Device Manufacturer · US , Houston , TX

Henley Intl. - FDA 510(k) Cleared Devices

44 submissions · 41 cleared · Since 1986
44
Total
41
Cleared
0
Denied
44 devices
26-44 of 44
Cleared Oct 30, 1989
TTS2600
K895334 · GZJ
Neurology · 61d
Cleared Apr 20, 1989
SURGICAL 'LASER' DRAPE
K884231 · KKX
General Hospital · 195d
Cleared Mar 03, 1989
AM TM SYRGICAL DRAPES
K882643 · KKX
General Hospital · 249d
Cleared Dec 15, 1988
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · GXY
Neurology · 62d
Cleared Jun 17, 1988
SURGICAL DUCT CLAMP (VINE)
K882169 · GDJ
General & Plastic Surgery · 24d
Cleared May 02, 1988
ENDOMED CV405
K880699 · IPF
Physical Medicine · 70d
Cleared Apr 13, 1988
ENDOMED 433
K870384 · LIH
Neurology · 439d
Cleared Sep 04, 1987
MODEL K210 AND K211 FLUIDOTHERAPY UNITS
K871802 · LSB
Physical Medicine · 119d
Cleared Sep 03, 1987
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · IMG
Physical Medicine · 83d
Cleared Jul 23, 1987
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · IMI
Physical Medicine · 41d
Cleared Jun 16, 1987
DYNATRON 438
K870515 · IPF
Physical Medicine · 131d
Cleared May 29, 1987
VASOTRAIN 447
K871107 · IRO
Physical Medicine · 71d
Cleared May 06, 1987
PELTIERTHERAPY(C) HEAT/COLD TREATMENT
K871112 · IMF
Physical Medicine · 48d
Cleared Apr 22, 1987
OMEGA T100
K870666 · GZJ
Neurology · 62d
Cleared Apr 22, 1987
OMEGA T200
K870667 · GZJ
Neurology · 62d
Cleared Nov 04, 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · KNT
Gastroenterology & Urology · 98d
Cleared Jun 26, 1986
JELTRODE
K861956 · GXY
Neurology · 37d
Cleared May 30, 1986
CURAMED 402 DIATHERMY UNIT
K861247 · IMJ
Physical Medicine · 58d
Cleared May 30, 1986
CURAPULS 419 DIATHERMY UNIT
K861248 · IMJ
Physical Medicine · 58d
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