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
3157 Obstetrics & Gynecology devices
Cleared
Jul 19, 1999
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
62d
Cleared
Jul 19, 1999
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
HIB
Speculum, Vaginal, Nonmetal
52d
Cleared
Jul 14, 1999
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
MQH
Microtools, Assisted Reproduction (pipettes)
121d
Cleared
Jul 14, 1999
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
MQK
Labware, Assisted Reproduction
114d
Cleared
Jul 14, 1999
BOVINE SERUM ALBUMIN (BSA)
MQL
Media, Reproductive
86d
Cleared
Jul 14, 1999
PVP (POLYVINYLPYRROLIDONE)
MQL
Media, Reproductive
86d
Cleared
Jul 08, 1999
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
KXO
Monitor, Pressure, Intrauterine
87d
Cleared
Jul 08, 1999
THERMOPLATE
MQG
Accessory, Assisted Reproduction
86d
Cleared
Jul 08, 1999
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
MQL
Media, Reproductive
80d
Cleared
Jul 08, 1999
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
MQL
Media, Reproductive
80d
Cleared
Jul 08, 1999
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
MQL
Media, Reproductive
80d
Cleared
Jul 06, 1999
LIFESTYLES XTRA PLEASURE
HIS
Condom
272d
Cleared
Jul 02, 1999
MODIFIED HAM'S F-10 WITH ALBUMIN
MQL
Media, Reproductive
70d
Cleared
Jul 02, 1999
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
MQL
Media, Reproductive
70d
Cleared
Jun 29, 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
HEB
Tampon, Menstrual, Unscented
89d
Cleared
Jun 29, 1999
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
MQG
Accessory, Assisted Reproduction
78d
Cleared
Jun 29, 1999
ORIBRUSH - STANDARD - B002
HHT
Spatula, Cervical, Cytological
53d
Cleared
Jun 29, 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
HHT
Spatula, Cervical, Cytological
53d
Cleared
Jun 18, 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
LTZ
Condom With Nonoxynol-9
80d
Cleared
Jun 17, 1999
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
HIS
Condom
90d
Cleared
Jun 15, 1999
CLIMAX
HIS
Condom
77d
Cleared
Jun 15, 1999
INVIGRA
HIS
Condom
55d
Cleared
Jun 08, 1999
PRODIMED MICROINJECTION PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
230d
Cleared
Jun 08, 1999
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
MQE
Needle, Assisted Reproduction
82d
Cleared
Jun 03, 1999
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
HIH
Hysteroscope (and Accessories)
77d
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