FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
474 results
457–474 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · NOP
Panbio Limited
Microbiology · 5d
Not Cleared Jun 16, 2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
DEN030002 · NGS
Spectral Diagnostics, Inc.
Microbiology · 63d
Not Cleared Apr 30, 2003
NIOX ARTICLE NO: 02-1000
DEN030001 · MXA
Aerocrine AB
Toxicology · 43d
Not Cleared Jan 31, 2003
BREASTVIEW VISUAL MAPPING SYSTEM
DEN020001 · NKA
Assurance Medical
Obstetrics & Gynecology · 248d
Not Cleared Aug 20, 2002
RETROX
DEN020003 · NIX
Auric Hearing Systems, Inc.
Ear, Nose, Throat · 60d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 51d
Not Cleared Feb 16, 2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
DEN000008 · NDS
Life Technologies, Inc.
Gastroenterology & Urology · 59d
Not Cleared Nov 20, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
DEN000010 · NBC
Biosite Incorporated
Chemistry · 5d
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