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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73489–73512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · HKY
Luneau SA
Ophthalmic · 94d
Cleared Feb 20, 2003
DUAL YELLOW LASER, MODEL D10B
K023899 · GEX
Norseld Pty., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 20, 2003
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
K023903 · PKL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Feb 20, 2003
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · LPH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 20, 2003
GELBFISH FLEX VASCULAR DILATOR
K030260 · DRE
Vascumetrix, LLC
Cardiovascular · 27d
Cleared Feb 20, 2003
CEM-OSTETIC BONE
K030266 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 24d
Cleared Feb 20, 2003
ACCOUSONIC PLUS, MODEL AP-170
K030410 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 13d
Cleared Feb 19, 2003
TRAVELAIR PORTABLE COMPRESSION SYSTEM
K022340 · JOW
Dynamic Air, Inc.
Cardiovascular · 216d
Cleared Feb 19, 2003
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
K022814 · LZA
Pt. Smartglove Indonesia
General Hospital · 177d
Cleared Feb 19, 2003
THE BREATHE EZ ANTI-SNORING DEVICE
K022891 · LRK
D&S Redhage
Dental · 173d
Cleared Feb 19, 2003
MCPULSE
K023238 · JOM
Meridian Co., Ltd.
Cardiovascular · 145d
Cleared Feb 19, 2003
CVSI PERIPHERAL BALLOON CATHETER
K023463 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 127d
Cleared Feb 19, 2003
ENDO-GLIDE GUIDEWIRE
K023603 · OCY
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 114d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · EZX
Implex Corp.
General & Plastic Surgery · 90d
Cleared Feb 19, 2003
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
K023906 · KPI
The Prometheus Group
Gastroenterology & Urology · 89d
Cleared Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · CFF
Helena Laboratories
Immunology · 64d
Cleared Feb 19, 2003
PRECISION CAPILLARIES FOR MICROMANIPULATION
K024302 · MQH
Brinkmann Instruments, Inc.
Obstetrics & Gynecology · 57d
Cleared Feb 19, 2003
NEXUS INJECTION SITE (NIS), MODEL NIS-1
K024363 · FPA
Nexus Medical, LLC
General Hospital · 50d
Cleared Feb 19, 2003
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6,...
K030137 · FPA
Avail Medical Products, Inc.
General Hospital · 36d
Cleared Feb 19, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K030148 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 35d
Cleared Feb 19, 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING...
K030157 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 34d