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
70729–70752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2003
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K032085 · GEX
Nidek, Inc.
General & Plastic Surgery · 88d
Cleared Oct 03, 2003
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · DPS
Remco Italia S.P.A.
Cardiovascular · 77d
Cleared Oct 03, 2003
MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100...
K032231 · ILY
Medx Electronics, Inc.
Physical Medicine · 74d
Cleared Oct 03, 2003
PLACER
K032349 · GZB
Advanced Neuromodulation Systems
Neurology · 95d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · DIC
Lin-Zhi International, Inc.
Toxicology · 53d
Cleared Oct 03, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032630 · LYZ
Kingswell International, Inc.
General Hospital · 38d
Cleared Oct 03, 2003
VIVATIP MICROWAVE ABLATION PROBE
K032702 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 03, 2003
MOSFET AUTOSENSE WIRELESS
K032725 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 30d
Cleared Oct 03, 2003
HEART 2006
K032736 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 29d
Cleared Oct 03, 2003
VACURECT VACUUM CONSTRICTION DEVICE
K032776 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 25d
Cleared Oct 02, 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · ELW
Harry J. Bosworth Co.
Dental · 149d
Cleared Oct 02, 2003
3D INVIVO BY CSIST
K031567 · LLZ
Chung-Shan Institute of Science and...
Radiology · 136d
Cleared Oct 02, 2003
SECTRA ORTHOPEDIC PACKAGE
K031590 · LLZ
Sectra-Imtec AB
Radiology · 134d
Cleared Oct 02, 2003
AQUABOSS ECORO DIA 50
K032004 · FIP
Lauer Ltd., Hong Kong
Gastroenterology & Urology · 94d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079 · JWH
Tornier
Orthopedic · 87d
Cleared Oct 02, 2003
I-BEAM
K032100 · IYE
Computerized Medical Systems, Inc.
Radiology · 86d
Cleared Oct 02, 2003
5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K032140 · DZE
Innova Life Sciences Corp.
Dental · 83d
Cleared Oct 02, 2003
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE...
K032177 · FDS
Olympus Opto-Electronics Co., Ltd.
Gastroenterology & Urology · 78d
Cleared Oct 02, 2003
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
K032210 · MQB
Alara, Inc.
Radiology · 73d
Cleared Oct 02, 2003
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS...
K032234 · EFB
Mk-Dent GmbH
Dental · 73d
Cleared Oct 02, 2003
MINICAT DENTOCAT
K032243 · JAK
Xoran Technologies, Inc.
Radiology · 72d
Cleared Oct 02, 2003
XIVE TG ABUTMENTS
K032302 · DZE
Friadent GmbH
Dental · 69d
Cleared Oct 02, 2003
ECHOENCODER
K032324 · LLZ
Icardiogram, Incorporated
Radiology · 66d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · EZX
Implex Corp.
General & Plastic Surgery · 64d