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
36745–36768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2014
Sternal Closure System
K142484 · HRS
Jace Medical, LLC
Orthopedic · 57d
Cleared Oct 31, 2014
SoftVue
K142517 · IYO
Delphinus Medical Technologies, Inc.
Radiology · 53d
Cleared Oct 31, 2014
Bard RiteCath Intermittent Urinary Catheter
K142575 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 30, 2014
NOVAPACS
K132853 · LLZ
Novarad Corp.
Radiology · 413d
Cleared Oct 30, 2014
VC150 VITAL SIGNS MONITOR
K133810 · MWI
Innokas Yhtyma
Cardiovascular · 318d
Cleared Oct 30, 2014
KJ EXTERNAL IMPLANT SYSTEM
K140051 · DZE
Kj Meditech Co., Ltd.
Dental · 294d
Cleared Oct 30, 2014
J2I IMPLANT SYSTEM
K140052 · DZE
Kj Meditech Co., Ltd.
Dental · 294d
Cleared Oct 30, 2014
ELIA SCL-70S IMMUNOASSAY
K140493 · LJM
Phadia GmbH
Immunology · 245d
Cleared Oct 30, 2014
ASTROGLIDE SENSUAL STRAWBERRY
K140590 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 237d
Cleared Oct 30, 2014
VELASII THERAPY LASER SYSTEM
K142078 · ILY
Aspen Laser Systems, LLC
Physical Medicine · 91d
Cleared Oct 30, 2014
ISO-GARD MASK
K142138 · CBN
Teleflexmedical, Inc.
Anesthesiology · 86d
Cleared CT Oct 30, 2014
Pico Way Laser System
K142372 · GEX
Candela Corpation
General & Plastic Surgery · 66d
Cleared Oct 30, 2014
Miltex N-Tralig Intraligamentary Syringe
K142414 · EJI
Integra LifeSciences Corporation
Dental · 63d
Cleared Oct 30, 2014
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · IYO
C.R. Bard, Inc.
Radiology · 58d
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