Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
40393–40416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 28, 2013
ILLUMASK ACNE LIGHT THERAPY MASK
K123999 · OLP
La Lumiere, LLC
General & Plastic Surgery · 245d
Cleared Aug 28, 2013
STALIF X
K130461 · OVD
Centinel Spine, Inc.
Orthopedic · 187d
Cleared Aug 28, 2013
BIORETEC ACTIVASCREW INTERFERENCE
K130716 · MAI
Bioretec, Ltd.
Orthopedic · 166d
Cleared Aug 28, 2013
LIDCO CNAP MODULE
K131048 · DXG
Lidco, Ltd.
Cardiovascular · 135d
Cleared Aug 28, 2013
RESTORE BUNION CORRECTION SYSTEM
K131061 · JDR
Nextremity Solutions
Orthopedic · 134d
Cleared Aug 28, 2013
COLIGN
K131124 · DTL
Jilin Coronado Medical , Ltd.
Cardiovascular · 128d
Cleared Aug 28, 2013
UGFT3
K131155 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Aug 28, 2013
SONICISION STERILIZATION TRAY
K131170 · KCT
Covidien, Formerly Valleylab, A...
General Hospital · 126d
Cleared Aug 28, 2013
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
K131221 · NQK
Biomonde
General & Plastic Surgery · 120d
Cleared Aug 28, 2013
CARESCAPE MONITOR B650
K131223 · MHX
GE Healthcare Finland Oy
Cardiovascular · 120d