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
31705–31728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2016
Integra External Fixation System
K160830 · KTT
Ascension Orthopedics
Orthopedic · 103d
Cleared Jul 06, 2016
LD-Oxi system
K160956 · MWI
Ld Technology, LLC
Cardiovascular · 92d
Cleared Jul 06, 2016
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
K160996 · MBI
Dunamis, LLC
Orthopedic · 89d
Cleared Jul 06, 2016
GC85A
K160997 · KPR
Samsung Electronics Co., Ltd.
Radiology · 86d
Cleared Jul 06, 2016
Easy-Load Lens Delivery System
K161012 · MSS
Bausch and Lomb, Inc.,
Ophthalmic · 86d
Cleared Jul 06, 2016
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key...
K161044 · DJC
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 84d
Cleared Jul 06, 2016
Cool Renewal
K161296 · GEH
Cool Renewal, LLC
General & Plastic Surgery · 58d
Cleared Jul 06, 2016
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
K161314 · BTT
Flexicare Medical Limited.
Anesthesiology · 56d
Cleared Jul 06, 2016
RadPRO® Mobile 40kW
K161345 · IZL
Sedecal., Sa.
Radiology · 54d
Cleared Jul 06, 2016
SPEC Model M13
K161395 · KXK
Source Production and Equipment Co.,...
Radiology · 48d
Cleared Jul 06, 2016
BD SafeAssist
K161553 · FMI
Becton, Dickinson and Company
General Hospital · 30d
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · LIP
Fujirebio Diagnostics,Inc.
Microbiology · 249d
Cleared Jul 05, 2016
LightStim Professional LED Bed
K153399 · ILY
Led Intellectual Properties, LLC
Physical Medicine · 224d
Cleared Jul 05, 2016
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
K153533 · DYB
Galt Medical Corp.
Cardiovascular · 209d
Cleared Jul 05, 2016
PicoWay Laser System
K160607 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 125d
Cleared Jul 05, 2016
LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp...
K160947 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 91d
Cleared Jul 01, 2016
Sorbact Foam Gentle Border, Sorbact Superabsorbent
K153674 · FRO
Abigo Medical AB
General & Plastic Surgery · 193d
Cleared Jul 01, 2016
Cure™ Anterior Cervical Plate (ACP) System
K160604 · KWQ
Meditech Spine, LLC
Orthopedic · 121d
Cleared Jul 01, 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904 · NKB
Medos International SARL
Orthopedic · 91d
Cleared Jul 01, 2016
PC ECG
K161302 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared Jul 01, 2016
INDIGO Aspiration System
K161523 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Jul 01, 2016
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement...
K161531 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Jun 30, 2016
Initial LiSi Press
K153136 · EIH
GC America, Inc.
Dental · 244d
Cleared Jun 30, 2016
Admira Fusion Flow
K153177 · EBF
Voco GmbH
Dental · 240d