Cook Ob/Gyn

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500October 27, 2006
K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITAugust 29, 2003
K023850SYDNEY IVF EMBRYO BIOPSY MEDIUMJanuary 22, 2003
K013597TAMPONADE UTERINE BALLOON CATHETER SETApril 17, 2002
K002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK September 18, 2000
K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KITSeptember 13, 2000
K983595TRANSMYOMETRIAL EMBRYO TRANSFER SETFebruary 8, 1999
K983596INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTEFebruary 5, 1999
K983642COOK MINI-INCUBATORFebruary 1, 1999
K983593OVUM PICK-UP ASPIRATION NEEDLESJanuary 21, 1999
K983591INTRATUBAL TRANSFER SETSDecember 21, 1998
K983590GIFT CATHETER SET/SDecember 21, 1998
K983594EMBRYO TRANSFER CATHETERS/SETSDecember 21, 1998
K983609COOK TEST TUBE HEATERDecember 16, 1998
K983587HYSTEROSCOPIC GIFT CATHETER SETSDecember 16, 1998
K931476NOVY CORNUAL CANNULATION SETJuly 28, 1995
K941298IUMC ENDOMETRIAL SAMPLERFebruary 13, 1995
K932114TUBAL LUMEN SUPPORTSeptember 27, 1994
K943970DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLESeptember 6, 1994
K911620STOVALL ENDOMETRIAL BRUSHJune 24, 1994