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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127921–127944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1989
LOW FUSING WHITE GOLD
K895056 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895060 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895063 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
SELECT 60
K895067 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
SELECT 40
K895069 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
SELECT WHITE
K895070 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
Cleared Dec 19, 1989
HUI MINI-FLEX
K895659 · HIG
Unimar, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 19, 1989
MICROMEDICS EAR, NOSE AND THROAT BURS
K895738 · EQJ
Micromedics, Inc.
Ear, Nose, Throat · 84d
Cleared Dec 19, 1989
PANCREATIC A-AMYLASE EPS
K895880 · CIL
Boehringer Mannheim Corp.
Chemistry · 75d
Cleared Dec 19, 1989
COBAS READY
K896007 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 67d
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