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
4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3169 Obstetrics & Gynecology devices
Cleared
Apr 16, 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
HIS
Condom
35d
Cleared
Apr 16, 1990
TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED
HIS
Condom
35d
Cleared
Apr 13, 1990
SPERM SELECT SYSTEM
HDR
Cap, Cervical
81d
Cleared
Apr 02, 1990
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
HDB
Extractor, Vacuum, Fetal
192d
Cleared
Mar 29, 1990
PERCU-SET(TM)
HIO
Sampler, Amniotic Fluid (amniocentesis Tray)
86d
Cleared
Mar 27, 1990
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
HIS
Condom
18d
Cleared
Mar 27, 1990
G.S.A. COLORED CONDOMS
HIS
Condom
18d
Cleared
Mar 16, 1990
OLYMPUS HYSTERORESECTOSCOPE
HIH
Hysteroscope (and Accessories)
88d
Cleared
Mar 05, 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
HGL
Transducer, Ultrasonic, Obstetric
194d
Cleared
Mar 05, 1990
HYSTEROSCOPE
HIH
Hysteroscope (and Accessories)
84d
Cleared
Feb 22, 1990
SPATULA FOR PAP SMEAR COLLECTION
HHT
Spatula, Cervical, Cytological
300d
Cleared
Feb 16, 1990
DGH A-SAN PROBE HOLDER
HDR
Cap, Cervical
35d
Cleared
Feb 06, 1990
LAPAROSCOPIC ACCESS SHEATH SET
HET
Laparoscope, Gynecologic (and Accessories)
48d
Cleared
Jan 23, 1990
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
HIS
Condom
126d
Cleared
Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
HFM
Monitor, Uterine Contraction, External (for Use In Clinic)
230d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices