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: Not cleared only ×
483 results
481–483 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Aug 20, 1999
THE 3PM EGG MACHINE
DEN990005 · MYE
3pm Co., Inc.
Gastroenterology & Urology · 39d
Not Cleared Jul 17, 1998
DIAMOND PROBE/PERIO 2000 SYSTEM
DEN980003 · MVH
Diamond General Development Corp.
Dental · 60d
Not Cleared May 29, 1998
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001 · MVA
Cranial Technologies, Inc.
Neurology · 59d