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
457–480 of 483
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010 · NTH
Vysis
Pathology · 61d
Not Cleared Nov 04, 2004
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
DEN040009 · MRX
Hamilton Thorne Biosciences
Obstetrics & Gynecology · 71d
Not Cleared Oct 12, 2004
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
DEN040007 · NRV
Digital Angel Corporation
General Hospital · 69d
Not Cleared Aug 24, 2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL...
DEN040002 · NQL
Perkinelmer Life Sciences, Inc.
Chemistry · 53d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP
Microgenics Corp.
Chemistry · 41d
Not Cleared Jun 25, 2004
CELLERATION MIST THERAPY SYSTEM
DEN040004 · NRB
Celleration
General & Plastic Surgery · 57d
Not Cleared May 21, 2004
GLUCATELL
DEN040003 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 60d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001 · NQI
Advanced Diagnostic Systems
Pathology · 19d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d
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