FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
97–120 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Not Cleared Jan 17, 2014
CYTOSCAN(R) DX
DEN130018 · PFX
Affymetrix, Inc.
Pathology · 30d
Cleared Jan 10, 2014
FLEXMAP 3D
K133302 · NSU
Luminex Corp.
Pathology · 77d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K130861 · MXZ
Dako North America, Inc.
Pathology · 256d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · NQN
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K124006 · PFR
Illumina, Inc.
Pathology · 328d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
K132750 · PFS
Illumina, Inc.
Pathology · 77d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · NQN
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · NQN
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021 · OEO
Philips Medical Systems Nederland B.V.
Pathology · 259d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · NOT
Ventana Medical Systems, Inc.
Pathology · 519d
Cleared Sep 06, 2013
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · NYI
Nanostring Technologies
Pathology · 246d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · PDO
Abbott Molecular, Inc.
Pathology · 111d
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794 · NQI
Veridex, LLC
Pathology · 90d
Cleared Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · MYA
Dako North America, Inc.
Pathology · 344d
Cleared Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 170d
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · MYA
Ventana Medical Systems, Inc.
Pathology · 719d
Cleared Dec 13, 2012
CELLTRACKS AUTOPREP SYSTEM
K122821 · NQI
Veridex, LLC
Pathology · 90d
Cleared Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
K111914 · OEO
Olympus America Inc. / Scientific...
Pathology · 412d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · NOT
Ventana Medical Systems, Inc.
Pathology · 28d
Cleared May 17, 2012
TISSUE OF ORIGIN TEST KIT FFPE
K120489 · OIW
Pathwork Diagnostics, Inc.
Pathology · 90d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · NQN
Ventana Medical Systems, Inc.
Pathology · 293d
Cleared Mar 16, 2012
RNARETAIN
K113420 · OZF
Asuragen, Inc.
Pathology · 119d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · NQN
Ventana Medical Systems, Inc.
Pathology · 248d