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
81265–81288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2000
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
K001978 · LTZ
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 40d
Cleared Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Aug 08, 2000
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
K002239 · IYN
Kontron Medical Systems Sas
Radiology · 15d
Cleared Aug 08, 2000
ULTRAGUIDE CT-GUIDE 1010
K002258 · JAK
Ultraguide , Ltd.
Radiology · 14d
Cleared Aug 07, 2000
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K001126 · LDJ
Alatex Scientific, Inc.
Toxicology · 122d
Cleared Aug 07, 2000
CONSENSUS KNEE SYSTEM
K001456 · JWH
Hayes Medical, Inc.
Orthopedic · 90d
Cleared Aug 07, 2000
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471 · LWJ
Implex Corp.
Orthopedic · 88d
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547 · JWY
Ab Biodisk
Microbiology · 81d
Cleared Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761 · JGS
Nova Biomedical Corp.
Chemistry · 59d
Cleared Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO
Diamedix Corp.
Microbiology · 56d
Cleared Aug 07, 2000
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K002134 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
K002196 · JJY
Bio-Rad
Chemistry · 18d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390 · HRS
Biomet, Inc.
Orthopedic · 608d
Cleared Aug 07, 2000
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 223d
Cleared Aug 04, 2000
ENRAF-NONIUS SONOPULS 190 SYSTEM
K000084 · IMI
Henley Healthcare, Inc.
Physical Medicine · 205d
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568 · LBT
Roche Diagnostics Corp.
Chemistry · 164d
Cleared Aug 04, 2000
SONIC, MODEL SO-100
K000593 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 164d
Cleared Aug 04, 2000
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001,...
K000653 · MRN
Pulmonox Medical Corp.
Anesthesiology · 158d
Cleared Aug 04, 2000
APEX MODULAR HIP STEM
K000788 · LPH
Apex Surgical, LLC
Orthopedic · 147d
Cleared Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
K001009 · DCK
Randox Laboratories, Ltd.
Immunology · 128d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · MEH
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
E-Z LINK CROSS CONNECTOR
K001470 · KWP
Depuyacromed
Orthopedic · 85d
Cleared Aug 04, 2000
TORQUE INSTRUMENT, MODEL 8500
K001476 · LXM
Spinalight, Inc.
Physical Medicine · 85d