FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128521–128544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1989
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL
K896144 · CGA
Cascade Medical, Inc.
Chemistry · 57d
Cleared Dec 19, 1989
TDX(R) BARBITURATES II ASSAY
K896550 · DIS
Abbott Laboratories
Toxicology · 32d
Cleared Dec 18, 1989
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
K893200 · LGD
Gull Laboratories, Inc.
Microbiology · 236d
Cleared Dec 18, 1989
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · LFZ
Gull Laboratories, Inc.
Microbiology · 234d
Cleared Dec 18, 1989
CONDOM (RUBBER LATEX) KILROY
K894533 · HIS
Rfsu
Obstetrics & Gynecology · 152d
Cleared Dec 18, 1989
300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895048 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
200 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895049 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895050 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
MONOGRAM I
K895051 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
.585 FINE GOLD SOLDER
K895052 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
.615 FINE GOLD SOLDER
K895053 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
.730 FINE GOLD SOLDER
K895055 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
HIGH FUSING WHITE GOLD
K895057 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
700 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895061 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895062 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
MONOGRAM II
K895064 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
MONOGRAM III
K895065 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
SELECT 50
K895068 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
DIATECH IGM-MP TEST
K895276 · LJZ
Diatech Diagnostica , Ltd.
Microbiology · 117d
Cleared Dec 18, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 89d
Cleared Dec 18, 1989
EBV-EA IFA KIT
K895652 · LSE
Organon Teknika Treyburn
Microbiology · 89d
Cleared Dec 18, 1989
LYNX-HIGH SPEED HANDPIECE
K895736 · EFB
Mti Precision Products
Dental · 83d
Cleared Dec 18, 1989
LITELINE VLC SOFT RELINE
K895742 · EBI
Dentsply Intl.
Dental · 83d
Cleared Dec 18, 1989
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · LYY
Safeskin Corp.
General Hospital · 80d