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
147049–147072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1985
BETA QUIK STAT
K852327 · JHI
Pacific Biotech, Inc.
Chemistry · 82d
Cleared Aug 20, 1985
AURALITE II
K852403 · HQG
Aura Lens Products
Ophthalmic · 75d
Cleared Aug 20, 1985
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
K852751 · GMQ
Preco, Inc.
Microbiology · 53d
Cleared Aug 20, 1985
OCULAB TONOPEN
K852774 · HKY
Oculab, Inc.
Ophthalmic · 50d
Cleared Aug 20, 1985
COOPER VISION SYSTEM VI U/S MODULE
K853070 · HQC
CooperVision, Inc.
Ophthalmic · 29d
Cleared Aug 20, 1985
CUDDLE CUSHION
K853185 · LDQ
The Cuddle Co.
General & Plastic Surgery · 21d
Cleared Aug 20, 1985
INTEGRITY EYE DROP GUIDE(MODIFICATION)
K853199
Integrity Optics, Inc.
Ophthalmic · 20d
Cleared Aug 20, 1985
ASO SLIDE EIKEN
K853276 · GTQ
Syn-Kit, Inc.
Microbiology · 15d
Cleared Aug 20, 1985
EMODREN EXCHANGEABLE PLASTIC BELLOWS
K853295 · GCY
Parexel Intl. Corp.
General & Plastic Surgery · 14d
Cleared Aug 19, 1985
ECS 502
K840717 · DRT
Robert Bosch Corp.
Cardiovascular · 549d
Cleared Aug 19, 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · DXG
Parke-Davis Co.
Cardiovascular · 461d
Cleared Aug 19, 1985
ESPE KETAC-BOND
K844845 · EBD
Espe GmbH (Us)
Dental · 249d
Cleared Aug 19, 1985
MEDIPART FACE MASK MP-XM-I
K850836 · IYT
Medipart Jerry Alexander
Radiology · 171d
Cleared Aug 19, 1985
MEDIPART FACE MASK & FILTER MP-30XM-I
K850837 · IYT
Medipart Jerry Alexander
Radiology · 171d
Cleared Aug 19, 1985
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · GMP
Ncs Diagnostics, Inc.
Microbiology · 126d
Cleared Aug 19, 1985
SARTORIUS MINISART FH 16534
K851816 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
SARTORIUS MINI-SART FH 16555
K851817 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
SARTORIUS MINI SART FH 16592
K851818 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
VSM MODELS A & B
K851916 · DRT
Physio-Control Corp.
Cardiovascular · 109d
Cleared Aug 19, 1985
DOME, DISPOSABLE, STERILE
K851989 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 104d
Cleared Aug 19, 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · ITX
Hewlett-Packard Co.
Radiology · 95d
Cleared Aug 19, 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · LKT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 91d
Cleared Aug 19, 1985
COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
K852564 · DXN
Takeda Medical, Inc.
Cardiovascular · 91d
Cleared Aug 19, 1985
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · JTN
Warner-Lambert Co.
Microbiology · 55d