FDA 510(k) Obstetrics & Gynecology Devices
FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview
FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.
Key categories:
- Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
- Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
- Breast pumps and lactation aids - electric and manual breast pumps
- Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
- Pregnancy test systems - hCG detection devices for professional and home use
4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
Cleared
Apr 07, 2010
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
LKF
Cannula, Manipulator/injector, Uterine
191d
Cleared
Apr 07, 2010
FEMVUE CORNUAL BALLOON CATHETER
LKF
Cannula, Manipulator/injector, Uterine
30d
Cleared
Apr 05, 2010
LIFEGLOBAL PROTEIN SUPPLEMENT
MQL
Media, Reproductive
227d
Cleared
Apr 02, 2010
INTRAUTERINE INSEMINATION (IUI) CATHETER
MQF
Catheter, Assisted Reproduction
228d
Cleared
Mar 30, 2010
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
HIH
Hysteroscope (and Accessories)
29d
Cleared
Mar 24, 2010
GYNCARE MORCELLEX TISSUE MORCELLATOR
HET
Laparoscope, Gynecologic (and Accessories)
51d
Cleared
Mar 24, 2010
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
36d
Cleared
Mar 12, 2010
VCARE DX
LKF
Cannula, Manipulator/injector, Uterine
115d
Cleared
Mar 11, 2010
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
LKF
Cannula, Manipulator/injector, Uterine
164d
Cleared
Mar 04, 2010
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
HGH
Cannula, Suction, Uterine
112d
Cleared
Mar 03, 2010
VIT KIT - FREEZE AND THAW
MQL
Media, Reproductive
135d
Cleared
Feb 24, 2010
LUBREASE FEMALE LUBRICANT
NUC
Lubricant, Personal
296d
Cleared
Feb 17, 2010
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
HGM
System, Monitoring, Perinatal
226d
Cleared
Feb 16, 2010
NON-STERILE DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
151d
Cleared
Feb 12, 2010
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
HIH
Hysteroscope (and Accessories)
189d
Cleared
Feb 05, 2010
TRUST DAM
MSC
Barrier, Std, Oral Sex
234d
Cleared
Feb 01, 2010
LAP LOOP
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
133d
Cleared
Jan 08, 2010
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
HDA
Forceps, Obstetrical
116d
Cleared
Dec 23, 2009
ONTEX TAMPON (UNSCENTED)
HEB
Tampon, Menstrual, Unscented
273d
Cleared
Dec 23, 2009
RAPID-I
MQK
Labware, Assisted Reproduction
272d
Cleared
Dec 23, 2009
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
HEB
Tampon, Menstrual, Unscented
190d
Cleared
Dec 04, 2009
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
HIH
Hysteroscope (and Accessories)
165d
Cleared
Dec 03, 2009
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
HCZ
Forceps, Surgical, Gynecological
79d
Cleared
Nov 13, 2009
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
HHE
Cup, Menstrual
150d
Cleared
Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
235d
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