FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72361–72384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC
Biosite Incorporated
Chemistry · 24d
Cleared Feb 21, 2003
JASUN, MODELS DT-01F AND DT-11F
K030361 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 18d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · JWZ
Xenotope Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 20, 2003
MEDLITE Q-SWITHCED LASER
K022709 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 190d
Cleared Feb 20, 2003
MAGIC INFUSION CATHETER
K023351 · KRA
Advanced Interventional Technologies,...
Cardiovascular · 136d
Cleared Feb 20, 2003
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
K023630 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 115d
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