Cook Urological, Inc. - FDA 510(k) Cleared Devices
Recent clearances: COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED), 3 WAY SILICONE FOLEY BALLOON CATHETER, COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
104
Total
102
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook Urological, Inc. Obstetrics & Gynecology ✕
31 devices
Cleared
May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
Obstetrics & Gynecology
281d
Cleared
Sep 03, 2009
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
Obstetrics & Gynecology
336d
Cleared
Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
Obstetrics & Gynecology
108d
Cleared
Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
Obstetrics & Gynecology
92d
Cleared
Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
Obstetrics & Gynecology
87d
Cleared
Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
Obstetrics & Gynecology
161d
Cleared
Mar 23, 2004
SYDNEY IVF PVP
Obstetrics & Gynecology
334d
Cleared
Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION...
Obstetrics & Gynecology
30d
Cleared
Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
Obstetrics & Gynecology
30d
Cleared
Dec 20, 2002
SYDNEY IVF HYALURONIDASE
Obstetrics & Gynecology
74d
Cleared
Aug 12, 2002
SYDNEY IVF CULTURE OIL
Obstetrics & Gynecology
54d
Cleared
Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
Obstetrics & Gynecology
51d