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
36169–36192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2014
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
K142851 · LPL
Unilens Corp., USA
Ophthalmic · 30d
Cleared Oct 30, 2014
Premium Surgiclip III
K142869 · FZP
Covidien
General & Plastic Surgery · 29d
Cleared Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material,...
K142878 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
KUBTEC X250
K141539 · IZL
Kub Technologies, Inc.
Radiology · 141d
Cleared Oct 29, 2014
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL...
K141912 · KTT
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 106d
Cleared Oct 29, 2014
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
K142050 · ODP
Nu Vasive, Incorporated
Orthopedic · 93d
Cleared Oct 29, 2014
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K142053 · OWI
Zimmer Spine, Inc.
Orthopedic · 92d
Cleared Oct 29, 2014
REBOSSIS
K142090 · MQV
Orthorebirth Co., Ltd.
Orthopedic · 89d
Cleared Oct 29, 2014
AIS MODULIFT VBR SYSTEM
K142150 · MQP
Aesculap Implant System, Inc.
Orthopedic · 85d
Cleared Oct 29, 2014
Ascendra Balloon Aortic Valvaloplasty Catheter
K142199 · OZT
Edwards Lifesciences
Cardiovascular · 79d
Cleared Oct 29, 2014
EpiAccess System
K142245 · DYB
Epiep, Inc.
Cardiovascular · 77d
Cleared Oct 29, 2014
cryoICE croablation probe
K142441 · GEH
AtriCure, Inc.
General & Plastic Surgery · 57d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
K142811 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
K142864 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
Leo Minor
K142984 · FSY
Sunnex, Inc.
General & Plastic Surgery · 13d
Cleared Oct 28, 2014
KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
K132771 · GEI
Qingdao Kingston Medical Devices, Ltd.
General & Plastic Surgery · 418d
Cleared Oct 28, 2014
HYPERQ ACS-100 SYSTEM
K140020 · DPS
Bsp-Biiological Signal Processing, Ltd.
Cardiovascular · 298d
Cleared Oct 28, 2014
ALLOX2 TISSUE EXPANDERS
K140383 · LCJ
Specialty Surgical Products, Inc.
General & Plastic Surgery · 256d
Cleared Oct 28, 2014
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE...
K141221 · EFB
Lares Research, Inc.
Dental · 169d
Cleared Oct 28, 2014
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
K141459 · IYN
Toshibamedical Systems Corporation
Radiology · 148d
Cleared Oct 28, 2014
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING...
K141686 · DWJ
Smith Medical Asd, Inc.
Cardiovascular · 127d
Cleared Oct 28, 2014
SMARTGRAFT 200 SYSTEM
K141713 · MUU
Ingeneron, Inc.
General & Plastic Surgery · 125d
Cleared Oct 28, 2014
#8C RENEGADE DENTAL HANDPIECE
K142063 · EFB
Handpiece Club, LLC
Dental · 90d
Cleared Oct 28, 2014
ZIMMER 3.1MM DENTAL IMPLANT
K142082 · DZE
Zimmer Dental, Inc.
Dental · 89d