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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81769–81792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002015 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d
Cleared Aug 09, 2000
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116 · DTQ
Medical Device Consultants, Inc.
Cardiovascular · 27d
Cleared Aug 09, 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118 · DTQ
Stoeckert Instrumente
Cardiovascular · 27d
Cleared Aug 09, 2000
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
K002221 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Aug 09, 2000
TRUE
K993913 · LIT
Infinity Extrusion & Engineering, Inc.
Cardiovascular · 266d
Cleared Aug 08, 2000
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 08, 2000
LA JOIE
K000736 · HED
Goomi Ehwa, Inc.
Obstetrics & Gynecology · 154d
Cleared Aug 08, 2000
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,...
K001404 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 08, 2000
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
K001406 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
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