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
127105–127128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1990
WOODLYN CLASSIC SLIT LAMP MODEL SMM
K900477 · HJO
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 21, 1990
WOODLYN FULL APERTURE TRIAL LENS SET
K900478 · HPC
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 20, 1990
EMS 8100
K895301 · IPF
Henley Intl.
Physical Medicine · 179d
Cleared Feb 20, 1990
SORBEX(TM) SOFT SPONGE
K895654 · NAD
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 153d
Cleared Feb 20, 1990
ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
K895690 · IMG
Excel Tech. , Ltd.
Physical Medicine · 151d
Cleared Feb 20, 1990
MULTISTIM PLUS
K895983 · IPF
Excel Tech. , Ltd.
Physical Medicine · 148d
Cleared Feb 20, 1990
4 SURE URINARY DRAIN BAG
K896727 · KNX
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 20, 1990
4 SURE URINARY LEG BAG
K896728 · FAQ
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 20, 1990
TOI-LIFT
K896814 · INN
Mill-Tech Ent., Inc.
Physical Medicine · 78d
Cleared Feb 20, 1990
EXCEL STIM
K896836 · IPF
Excel Tech. , Ltd.
Physical Medicine · 99d
Cleared Feb 20, 1990
EXCEL STIM II
K896908 · IPF
Excel U.S.A.
Physical Medicine · 71d
Cleared Feb 20, 1990
SKYTRON MODEL 1100 AND MODEL 142
K900290 · JEA
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 29d
Cleared Feb 20, 1990
DANNIFLEX CPM 880(TM)
K900581 · JFA
Buckman Co., Inc.
Physical Medicine · 13d
Cleared Feb 20, 1990
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
K900600 · INI
Invacare Corp.
Physical Medicine · 12d
Cleared Feb 16, 1990
IVEX MODEL NO. BP 3000 BREASTPUMP
K893545 · HGX
Ivex Medical, Inc.
Obstetrics & Gynecology · 284d
Cleared Feb 16, 1990
RHINOTHERM ULTRA 2
K894734 · KFZ
Twinmed Products, Inc.
Anesthesiology · 207d
Cleared Feb 16, 1990
SURGICAL GLOVES
K895018 · KGO
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 192d
Cleared Feb 16, 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 169d
Cleared Feb 16, 1990
EXEL SAFELET CATHETER
K895768 · FOZ
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL HUBER NEEDLE
K895769 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL SPINAL NEEDLES
K895771 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL INDWELLING CATHETER
K895772 · FDZ
Exel Intl.
Gastroenterology & Urology · 143d
Cleared Feb 16, 1990
AUTOPEN
K895890 · FMF
Ulster Scientific, Inc.
General Hospital · 134d
Cleared Feb 16, 1990
CHOLESTEROL TEST KIT
K895951 · CHH
Elite Technology, Inc.
Chemistry · 128d