Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Not cleared only ×
490 results
481–490 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Aug 16, 2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
DEN000007 · NBT
Inova Diagnostics, Inc.
Immunology · 29d
Not Cleared Apr 28, 2000
EROS-CLITORAL THERAPY DEVICE (CTD)
DEN000006 · NBV
Urometrics, Inc.
Obstetrics & Gynecology · 1d
Not Cleared Feb 29, 2000
QUICKAIR CHOKE RELIEVER, MODEL 59-001A
DEN000004 · MZT
Maet Industries, Inc.
Anesthesiology · 32d
Not Cleared Feb 22, 2000
KAVO DIAGNODENT
DEN990002 · NBL
Kavo America
Dental · 225d
Not Cleared Feb 15, 2000
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000
DEN990008 · NAK
Wallac, Inc.
Chemistry · 57d
Not Cleared Feb 09, 2000
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
DEN000002 · NAM
Urosurge, Inc.
Gastroenterology & Urology · 13d
Not Cleared Jan 11, 2000
OHMEDA INOVENT DELIVERY SYSTEM
DEN000001 · MRN
Ohmeda Medical
Anesthesiology · 4d
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