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

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175,820 results
36841–36864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2014
LIGHT SCALPEL
K141658 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 124d
Cleared Oct 22, 2014
UPCERA COLORING LIQUID (I AND II )
K141723 · EIH
Liaoning Upcera Co., Ltd.
Dental · 118d
Cleared Oct 22, 2014
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
K141724 · EIH
Liaoning Upcera Co., Ltd.
Dental · 118d
Cleared Oct 22, 2014
DUAL SWITCH
K141908 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 99d
Cleared Oct 22, 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · HSB
Zimmer, Inc.
Orthopedic · 68d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579 · HRS
Zimmer, Inc.
Orthopedic · 37d
Cleared Oct 22, 2014
VALOR Hindfoot Fusion Nail System
K142602 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2014
Vericore Zirconia Blanks
K142670 · EIH
Whip Mix Corporation
Dental · 33d
Cleared Oct 22, 2014
VERADIUS UNITY
K142708 · OWB
Philips Medical Systems Nethrlands BV
Radiology · 30d
Cleared Oct 21, 2014
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140197 · CAC
Teleflexmedical, Inc.
Anesthesiology · 267d
Cleared Oct 21, 2014
CD HORIZON SPINAL SYSTEM
K141604 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 127d
Cleared Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · JWY
Thermo Fisher Scientific
Microbiology · 123d
Cleared Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 106d
Cleared Oct 21, 2014
VIORA V-TOUCH
K141904 · GEI
Viora , Ltd.
General & Plastic Surgery · 99d
Cleared Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared CT Oct 21, 2014
ERCHONIA SHL
K142042 · OLI
Erchonia Corporation
General & Plastic Surgery · 85d
Cleared Oct 21, 2014
Xia 3 Spinal System
K142381 · NKB
Stryker Corp.
Orthopedic · 56d
Cleared Oct 20, 2014
SKORE AND MULTIPLE BRANDS
K132490 · HIS
Ttk Protective Devices Limited...
Obstetrics & Gynecology · 438d
Cleared Oct 20, 2014
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · PEK
Life Spine, Inc.
Orthopedic · 263d
Cleared Oct 20, 2014
SIMPLE T YOUTH NASAL MASK
K140268 · BZD
Respironics, Inc.
Anesthesiology · 250d
Cleared Oct 20, 2014
IONOSTAR MOLAR
K140993 · EMA
Voco GmbH
Dental · 186d
Cleared Oct 20, 2014
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · ODP
Spinefrontier, Inc.
Orthopedic · 87d
Cleared Oct 17, 2014
AERONEB SOLO
K133360 · CAF
Aerogen, Ltd.
Anesthesiology · 350d
Cleared Oct 17, 2014
BONASTENT TRACHEAL / BRONCHIAL
K140472 · JCT
Endochoice, Inc.
Anesthesiology · 234d