FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39793–39816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2013
SYNGO CT PULMO 3D
K123540 · JAK
Siemens Medical Systems, Inc.
Radiology · 283d
Cleared Aug 29, 2013
ARCHITECT IVANCOMYCIN
K123947 · LEH
Biokit, S.A.
Toxicology · 251d
Cleared Aug 29, 2013
MAVEN PRO
K130242 · LLZ
Nsequence
Radiology · 210d
Cleared Aug 29, 2013
ENDOWRIST ONE VESSEL SEALER
K130266 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 206d
Cleared Aug 29, 2013
OMNI-VUE 2 SYSTEM
K130374 · LLZ
Genesis Digital Imaging, Inc.
Radiology · 196d
Cleared Aug 29, 2013
ENSITE VELOCITY SYSTEM
K130727 · DQK
St Jude Medical
Cardiovascular · 164d
Cleared Aug 29, 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · KWQ
Nuvasive, Inc.
Orthopedic · 153d
Cleared Aug 29, 2013
ASPIRON ACP SYSTEM
K131200 · KWQ
U&I Corporation
Orthopedic · 122d
Cleared Aug 29, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · LZG
Insulet Corporation
General Hospital · 115d
Cleared Aug 29, 2013
CR 12-X DIGITIZER
K131408 · MQB
Agfa Healthcare N.V.
Radiology · 106d
Cleared Aug 29, 2013
EZDENTI-I
K131594 · LLZ
Ewoosoft Co., Ltd.
Radiology · 87d
Cleared Aug 29, 2013
FRESENIUS DRY ACID DISSOLUTION UNITS
K131611 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 87d
Cleared Aug 29, 2013
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST...
K131614 · NUJ
Covidien
General & Plastic Surgery · 87d
Cleared Aug 29, 2013
EZ3D-I, E3
K131616 · LLZ
Ewoosoft Co., Ltd.
Radiology · 87d
Cleared Aug 29, 2013
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
K131635 · MBI
Rotation Medical, Inc.
Orthopedic · 86d
Cleared Aug 29, 2013
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · OZE
Quidel Corp.
Microbiology · 78d
Cleared Aug 29, 2013
EVIS EXERA III VIDEO SYSTEM
K131780 · FDF
Olympus Medical Systems Corp.
Gastroenterology & Urology · 73d
Cleared Aug 29, 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR...
K132012 · KWQ
Zimmer Spine, Inc.
Orthopedic · 59d
Cleared Aug 29, 2013
CONCIERGE GUIDING CATHETER
K132409 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Aug 29, 2013
MZ1000
K132413 · FPA
Care Fusion
General Hospital · 27d
Cleared Aug 29, 2013
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR
K132587 · LLZ
Ned Display Solutions , Ltd.
Radiology · 13d
Cleared Aug 28, 2013
POWDERED LATEX SURGEON'S GLOVE
K121925 · KGO
Suzhou Colour-Way Enterprise...
General Hospital · 422d
Cleared Aug 28, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
K122197 · DHB
Phadia US, Inc.
Immunology · 400d
Cleared Aug 28, 2013
DERMISEB CREAM
K123724 · FRO
Igi Laboratories, Inc.
General & Plastic Surgery · 267d