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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
172633–172656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092 · CIX
Harleco
Chemistry · 20d
Cleared Feb 07, 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161 · DHN
Zeus Scientific, Inc.
Immunology · 7d
Cleared Feb 06, 1978
ENDOCARDIAL PACING ELECTRODE
K772309 · DTB
Coratomic, Inc.
Cardiovascular · 59d
Cleared Feb 06, 1978
ANESTHESIA TRAY, CAUDAL
K780120 · CAZ
Kendall Research Center
Anesthesiology · 14d
Cleared Feb 06, 1978
IMPLANT, HINGE TOE, FLEX.
K780132 · KWH
Dow Corning Corp. Healthcare...
Orthopedic · 13d
Cleared Feb 06, 1978
ELBOW PROTECTOR
K780171 · FMP
Stat Medical Corp.
General Hospital · 4d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-COMP. 3
K772073 · DBI
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN
K772074 · DDI
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT
K772075 · DAY
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.
K772076 · CZP
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
K772077 · DEW
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN
K772078 · DAB
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
K772079 · DFL
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
K772080 · DEM
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
HEMATOLOGY REFERENCE CONTROLS
K772195 · JPK
R&D Systems, Inc.
Hematology · 67d
Cleared Feb 03, 1978
LAS-R HUMAN ANTITHROMBIN III TEST
K772328 · JBQ
Hyland Therapeutic Div., Travenol...
Immunology · 44d
Cleared Feb 03, 1978
LAS-R HUMAN PREALBUMIN TEST
K772329 · JZJ
Hyland Therapeutic Div., Travenol...
Immunology · 44d
Cleared Feb 03, 1978
HUMAN FOLLICLE STIMULATING HORMONE
K780016 · CGI
Pcl-Ria, Inc.
Immunology · 31d
Cleared Feb 03, 1978
CARDIOMETER
K780117 · DRT
Med General
Cardiovascular · 11d
Cleared Feb 03, 1978
HTSH RIA
K780122 · KHO
Abbott Laboratories
Toxicology · 11d
Cleared Feb 03, 1978
ANTICONVULSANT CONTROL SERUM
K780142 · LAS
Mcdonnell Douglas Corp.
Toxicology · 8d
Cleared Feb 02, 1978
VALVE ANESTHETIC
K771892 · CAD
Promed Corp.
Anesthesiology · 119d
Cleared Feb 02, 1978
ELECTROCARDIOGRAPH TRANSMITTER, 536
K772186 · DXH
Intermedics, Inc.
Cardiovascular · 69d
Cleared Feb 02, 1978
BUBBLE-TYPE OXYGENATOR
K772284 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 52d