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
74833–74856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · DLJ
Lin-Zhi International, Inc.
Toxicology · 43d
Cleared Jun 18, 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · ITI
Invacare Corp.
Physical Medicine · 27d
Cleared Jun 17, 2002
NAKAO SNARE II AND NAKAO SNARE III
K020891 · FDI
Granit Medical Innovations
Gastroenterology & Urology · 90d
Cleared Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · IZL
GE Medical Systems
Radiology · 80d
Cleared Jun 17, 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070...
K021081 · DFZ
The Binding Site, Ltd.
Immunology · 75d
Cleared Jun 17, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181 · JWY
Dade Microscan, Inc.
Microbiology · 63d
Cleared Jun 17, 2002
BLOOD-PRESSURE METER
K021252 · DXN
Idt Technology Limited
Cardiovascular · 59d
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · KHE
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Jun 17, 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 13d
Cleared Jun 14, 2002
AIRCAST, MODEL #3011
K013297 · JOW
Millenium Reprocessing Services, Inc.
Cardiovascular · 254d
Cleared Jun 14, 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · GWJ
Fischer-Zoth Audiologic Systems, Inc.
Neurology · 193d
Cleared Jun 14, 2002
ENDOMAP
K014113 · HAW
Siemens Medical Solutions USA, Inc.
Neurology · 182d
Cleared Jun 14, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL...
K020857 · DRN
Vasomedical, Inc.
Cardiovascular · 88d
Cleared Jun 14, 2002
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL,...
K020896 · DTE
Osypka Medical, Inc.
Cardiovascular · 87d
Cleared Jun 14, 2002
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
K020907 · IKT
Medicotest A/S
Neurology · 86d
Cleared Jun 14, 2002
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · GCJ
Sopro
General & Plastic Surgery · 85d
Cleared Jun 14, 2002
RADIUS SNARE
K021441 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 39d
Cleared Jun 14, 2002
HEMOGLOBIN A1C CONTROL
K021484 · LCP
Canterbury Scientific , Ltd.
Hematology · 37d
Cleared Jun 14, 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · EBI
Imtec Corp.
Dental · 31d
Cleared Jun 14, 2002
MEDGEM
K021605 · BZL
Healthetech, Inc.
Anesthesiology · 29d
Cleared Jun 14, 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · IOR
Vestil Manufacturing Corp.
Physical Medicine · 8d
Cleared Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K013022 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 279d
Cleared Jun 13, 2002
X-IMAGE DIGITAL X-RAY SYSTEM
K020588 · MUH
Escape Technology, Inc.
Radiology · 111d
Cleared Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603 · DCN
Good Biotech Corp.
Chemistry · 108d