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
141121–141144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1987
THE IMAGE/R
K862294 · LLZ
Quantum Diagnostics, Ltd.
Radiology · 211d
Cleared Jan 14, 1987
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
K862483 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 198d
Cleared Jan 14, 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · DSK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 155d
Cleared Jan 14, 1987
DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE
K863132 · LLZ
General Electric Co.
Radiology · 152d
Cleared Jan 14, 1987
SYSTEM 90 TRANSPORT
K863219 · DSP
Datascope Corp.
Cardiovascular · 147d
Cleared Jan 14, 1987
CARDS(TM) - EARLY PREGNANCY TEST
K863341 · LCX
Pacific Biotech, Inc.
Chemistry · 139d
Cleared Jan 14, 1987
MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER
K863532 · FRN
Parker Hannifin Corp.
General Hospital · 127d
Cleared Jan 14, 1987
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
K863842 · KLT
Miles Laboratories, Inc.
Toxicology · 105d
Cleared Jan 14, 1987
E-Z HOLD - #4060
K864190 · KMK
John F. Greer Co., Inc.
General Hospital · 79d
Cleared Jan 14, 1987
PALMER OBSTETRIC BRACE
K864194 · KNC
Ad-Tech Medical Instrument Corp
Obstetrics & Gynecology · 79d
Cleared Jan 14, 1987
FRAZIER SUCTION TUBE
K864382 · EQH
Luxtec Corp.
Ear, Nose, Throat · 70d
Cleared Jan 14, 1987
LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS
K864383 · EQH
Luxtec Corp.
Ear, Nose, Throat · 70d
Cleared Jan 14, 1987
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
K864623 · KNA
Xanmed Corp.
Obstetrics & Gynecology · 50d
Cleared Jan 14, 1987
ERYPUR B
K864636 · CAK
Organon Teknika Corp.
General Hospital · 49d
Cleared Jan 14, 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · DRX
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jan 14, 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · JJS
Ciba Corning Diagnostics Corp.
Chemistry · 9d
Cleared Jan 13, 1987
AIR CARE AIR SANITIZER
K860132 · FRA
Cooper-Hewitt Electric Co.
General Hospital · 364d
Cleared Jan 13, 1987
CHEMTROL(TM)
K862565 · JJY
G.B.F. Industries, Inc.
Chemistry · 190d
Cleared Jan 13, 1987
AST S.C.E. (GOT)
K863054 · CIT
J. D. Assoc.
Chemistry · 154d
Cleared Jan 13, 1987
PEG 6,000
K863103 · CHH
J. D. Assoc.
Chemistry · 153d
Cleared Jan 13, 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · GWF
Cadwell Laboratories, Inc.
Neurology · 148d
Cleared Jan 13, 1987
LAD MODEL 535 LUMINOMETER
K864201 · JJQ
Los Alamos Diagnostics
Chemistry · 78d
Cleared Jan 13, 1987
REVEAL COLOUR STREP A ZL16
K864206 · GTZ
Wellcome Diagnostics
Microbiology · 78d
Cleared Jan 13, 1987
LUXTEC LIGHT SOURCES
K864385 · FCW
Luxtec Corp.
Gastroenterology & Urology · 69d