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
361–384 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Dec 18, 2014
AMIGO REMOTE CATHETER SYSTEM
DEN140009 · PJB
Catheter Robotics, Inc.
Cardiovascular · 303d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · PJI
Wallac OY
Pathology · 299d
Not Cleared Nov 26, 2014
HEARTFLOW FFRCT
DEN130045 · PJA
Heartflow
Cardiovascular · 387d
Not Cleared Nov 17, 2014
BrainScope Ahead 100
DEN140025 · PIW
Brainscope Company, Inc.
Neurology · 89d
Not Cleared Nov 07, 2014
ZAP-IT!
DEN100024 · OSG
Ecobrands , Ltd.
Neurology · 1520d
Not Cleared Nov 07, 2014
ZANZA-CLICK
DEN130019 · OSG
Tecnimed S.R.L.
Neurology · 617d
Not Cleared Oct 14, 2014
INFLOW INTRAURETHRAL VALVE-PUMP
DEN130044 · PIH
Vesiflo, Inc.
Gastroenterology & Urology · 354d
Not Cleared Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
DEN140019 · PII
T2biosystems, Inc.
Microbiology · 118d
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Astute Medical, Inc.
Chemistry · 457d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Not Cleared Aug 20, 2014
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
DEN140001 · PHF
Kronus Market Development Associates,...
Immunology · 65d
Not Cleared Aug 19, 2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
DEN140016 · PHV
Dexcom, Inc.
Chemistry · 119d
Not Cleared Jun 26, 2014
REWALK
DEN130034 · PHL
Argo Medical Technologies, Inc.
Neurology · 374d
Not Cleared Jun 06, 2014
EEVA 2.0
DEN120015 · PBH
Auxogyn, Inc.
Obstetrics & Gynecology · 651d
Not Cleared May 29, 2014
EUROIMMUN ANTI-PLA2R IFA
DEN140002 · PGV
Euroimmun US
Immunology · 62d
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · PGI
Diagnostic Hybrids, Inc.
Microbiology · 81d
Not Cleared May 09, 2014
DEKA ARM SYSTEM
DEN120016 · PAE
Deka Integrated Solutions Corporation
Physical Medicine · 693d
Not Cleared May 09, 2014
PIXEL 3 SYSTEM
DEN130015 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 459d
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · PGX
Quidel Corporation
Microbiology · 22d
Not Cleared Apr 03, 2014
XSTAT
DEN130016 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 428d
Not Cleared Mar 28, 2014
IOGYN SYSTEM
DEN130040 · PGT
Iogyn, Inc.
Obstetrics & Gynecology · 210d
Not Cleared Mar 21, 2014
SIMPLEXA HSV 1&2 DIRECT
DEN130049 · PGH
Focus Diagnostics
Microbiology · 116d
Not Cleared Mar 11, 2014
CEFALY
DEN120019 · PCC
Stx-Med Sprl
Neurology · 453d
Not Cleared Mar 04, 2014
AIRPURGE
DEN080009 · OKL
Anesthesia Safety Products, LLC
General Hospital · 1952d