Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
141721–141744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 13, 1987
DART PHENOBARBITAL ASSAY SYSTEM
K864612 · LFN
Coulter Electronics, Inc.
Toxicology · 50d
Cleared Jan 13, 1987
FOUR TANK DISSOLUTION MODULE
K864635 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 49d
Cleared Jan 13, 1987
UREA NITROGEN(BUN), COLORIMETRIC METHOD
K864742 · CDL
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743 · CEK
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
CREATINE PHOSPHOKINASE (CK)
K864744 · CGS
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · JKA
Dynatech Laboratories, Inc.
Chemistry · 33d
Cleared Jan 13, 1987
ALKALINE PHOSPHATASE
K864905 · CJE
Tech-Co, Inc.
Chemistry · 29d
Cleared Jan 13, 1987
H-H SUBGALEAL TROCAR
K865075 · GYK
Holter-Hausner Intl.
Neurology · 15d
Cleared Jan 13, 1987
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
K865102 · LES
Sclavo, Inc.
Toxicology · 20d
Cleared Jan 12, 1987
EDP-20 PACEMAKER
K860036 · DXY
Biotronik Sales, Inc.
Cardiovascular · 371d