FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127873–127896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1989
TAMPAX TAMPON
K896989 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 10d
Cleared Dec 22, 1989
KOTEX SECURITY TAMPONS (SEVERAL TYPE)
K896994 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 11d
Cleared Dec 22, 1989
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
K897012 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 2d
Cleared Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · KGI
Hologic, Inc.
Radiology · 297d
Cleared Dec 21, 1989
ARTECH TYPE SS SUBMERGED SCREW IMPLANT
K891346 · DZE
Artech Corp.
Dental · 286d
Cleared Dec 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892633 · LYY
Gobo Intl.
General Hospital · 255d
Cleared Dec 21, 1989
HEATED RESPIRATORY HUMIDIFIER
K892817 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 248d
Cleared Dec 21, 1989
PATIENT EXAMINATION GLOVES
K893632 · LYY
Pro Asia, Inc.
General Hospital · 225d
Cleared Dec 21, 1989
ISODENT
K894058 · EIA
Eurodent, Inc.
Dental · 197d
Cleared Dec 21, 1989
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
K894653 · KGC
Superior Biosystems, Inc.
Gastroenterology & Urology · 150d
Cleared Dec 21, 1989
WILTEK GASTRIC FEEDING TUBE
K894860 · FPD
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK PAPILLOTOME
K894861 · KNS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK GRASPING FORCEPS
K894862 · OCZ
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK CYTOLOGY BRUSH
K894863 · FDX
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BALLOON STONE EXTRACTOR
K894865 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK STONE EXTRACTOR
K894866 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK E.R.C.P. CATHETER
K894867 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK VARICES INJECTION NEEDLE
K894868 · FBK
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK POLYPECTOMY SNARE
K894869 · FDI
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · BSS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BILIARY STENT SET
K894871 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
PLATELIA RUBELLA IGG KIT
K894946 · LFX
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 140d
Cleared Dec 21, 1989
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · EBI
American Orthodontics
Dental · 87d
Cleared Dec 21, 1989
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748 · KHS
Catachem, Inc.
Chemistry · 86d