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
128497–128520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1989
TALLADIUM TILITE CERAMIC ALLOY
K894085 · EJH
Talladium, Inc.
Dental · 195d
Cleared Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · DRO
Nihon Kohden America, Inc.
Cardiovascular · 155d
Cleared Dec 20, 1989
LATEX PATIENT EXAMINATION GLOVES
K894900 · LYY
Fujian Ming Sheng Chemistry
General Hospital · 141d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · DTB
Pacesetter Systems
Cardiovascular · 103d
Cleared Dec 20, 1989
PLASTIC TOOTH REINFORCEMENT KIT
K895758 · EBL
Nanzee Dental Products
Dental · 85d
Cleared Dec 20, 1989
INFLATION PRO II
K895836 · MAV
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Dec 20, 1989
REVISED PATIENT EXAMINATION GLOVES
K896411 · LYY
Pt. Trihasta Loka Persada
General Hospital · 42d
Cleared Dec 20, 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · DTB
Possis Medical, Inc.
Cardiovascular · 41d
Cleared Dec 20, 1989
TOYOSUYA LATEX EXAMINATION GLOVES
K896489 · LYY
Toyosuya Sdn Bhd
General Hospital · 37d
Cleared Dec 19, 1989
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K891691 · DIE
Bio-Rad
Toxicology · 272d
Cleared Dec 19, 1989
SYS*STIM 206A
K893878 · IPF
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 19, 1989
SYS*STIM 207A
K893879 · IPF
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175 · JHI
Serono-Baker Diagnostics, Inc.
Chemistry · 187d
Cleared Dec 19, 1989
.650 FINE GOLD SOLDER
K895054 · EJT
Leach and Dillon Co., Inc.
Dental · 133d
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