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
31129–31152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 30, 2016
Repagyn vaginal suppositories
K153372 · NUC
Farma-Derma S.R.L.
Obstetrics & Gynecology · 220d
Cleared Jun 30, 2016
VITA ENAMIC Implant Solutions (IS)
K153645 · NHA
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 192d
Cleared Jun 30, 2016
STERIZONE Sterilizer
K153689 · PJJ
Tso3, Inc.
General Hospital · 190d
Cleared Jun 30, 2016
RTHawk, HeartVista Cardiac Package
K153740 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jun 30, 2016
3 Series Phototherapy Unit
K153749 · FTC
Daavlin Distributing Company
General & Plastic Surgery · 184d
Cleared Jun 30, 2016
ViaValve Safety I.V. Catheter
K160235 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 150d
Cleared Jun 30, 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · ELW
Kerr Corporation
Dental · 134d
Cleared Jun 30, 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 115d
Cleared Jun 30, 2016
Relizorb
K161247 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
K161495 · OOI
Luminex Corporation
Microbiology · 29d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
Arthrosurface Bone Screws
K161539 · HWC
Arthrosurface, Inc.
Orthopedic · 27d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A...
K161556 · OZE
Centers For Disease Control and...
Microbiology · 24d