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
153529–153552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1984
TOTAL BILIRUBIN
K840111 · CIG
Fisher Scientific Co., LLC
Chemistry · 69d
Cleared Mar 19, 1984
CURIETRON
K840127 · JAQ
Syncor Intl. Corp.
Radiology · 68d
Cleared Mar 19, 1984
EMIT ST URINE ETHYL ALCOHOL ASSAY
K840171 · DML
Syva Co.
Toxicology · 62d
Cleared Mar 19, 1984
LH QUIK RIA KIT
K840174 · CEP
Pacific Biotech, Inc.
Chemistry · 62d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183 · FOZ
Parke-Davis Co.
General Hospital · 62d
Cleared Mar 19, 1984
EMIT ST SERUM BARBITURATE ASSAY
K840194 · DIS
Syva Co.
Toxicology · 61d
Cleared Mar 19, 1984
BLOOD UREA NITROGEN REAGENT SYS
K840213 · JGZ
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
CALCIUM REAGENT SYS
K840214 · CHZ
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
PHOSPHORUS REAGENT SYSTEM
K840215 · CEO
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
SODIUM/POTASSIUM REAGENT SYS
K840216 · JGT
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
CONTROL COVER GOWN
K840229 · FYC
Kimberly-Clark Corp.
General Hospital · 59d
Cleared Mar 19, 1984
EMIT ST SERUM BENZODIAZEPINE ASSAY
K840236 · JXM
Syva Co.
Toxicology · 59d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840355 · FOZ
Parke-Davis Co.
General Hospital · 53d
Cleared Mar 19, 1984
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · JAA
Advanced Technology Laboratories, Inc.
Radiology · 53d
Cleared Mar 19, 1984
STOPCOCKS & EXTENSION TUBES
K840394 · FMG
American Pharmaseal Div. Ahsc
General Hospital · 49d
Cleared Mar 19, 1984
INFUSION SET-STERILE
K840409 · FPA
Loversan
General Hospital · 48d
Cleared Mar 19, 1984
SOLUTION ADMIN. SET STERILE
K840410 · FPA
Loversan
General Hospital · 48d
Cleared Mar 19, 1984
BLOOD & PLASMA ADMIN. DEV-STERILE
K840411 · BRZ
Loversan
General Hospital · 48d
Cleared Mar 19, 1984
SYS MACRODUCT SWEAT COLLECTION SYS 3600
K840472 · KTB
Wescor, Inc.
Physical Medicine · 45d
Cleared Mar 19, 1984
E-Z OPEN DUST COVERS
K840595 · FRG
Plasti-Products, Inc.
General Hospital · 39d
Cleared Mar 19, 1984
VERIFY PREGNANCY TEST KIT
K840602 · LCX
O.T.C. Diagnostics, Inc.
Chemistry · 38d
Cleared Mar 19, 1984
BERNIER ARM SUPPORT
K840653 · FNJ
T.C. Toll Corp.
General Hospital · 33d
Cleared Mar 19, 1984
ECU 1218
K840808 · IQA
Rehab Technology, Inc.
Physical Medicine · 24d
Cleared Mar 19, 1984
ANESTHESIA VENTILATOR CIRCUIT
K840850 · CAI
The Kendal Co.
Anesthesiology · 24d