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
167593–167616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1980
A,FSC LYOPHILIZED HEMO CONTROL
K800855 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
K800856 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
OMNISTIK, MQ 501GS
K800860 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 13d
Cleared Apr 29, 1980
FERRO-QUANT TM FE 59 TEST KIT
K800868 · JQG
Mallinckrodt Critical Care
Chemistry · 12d
Cleared Apr 29, 1980
ANTICONVULSANTS TOXICOLOGY CONTROL
K800882 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
CARDIACS I TOXICOLOGY CONTROL
K800883 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
CARDIACS II TOXICOLOGY CONTROL
K800884 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
BARBITURATES TOXICOLOGY CONTROL
K800885 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
K800886 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS SALICYLATE TX CONTROL
K800887 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
TRICYCLIC ANTIDEPRESSANT II TX CONTROL
K800889 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
PREMIER TRIPLE TRAY
K800900 · EHY
Premier Dental Products Co.
Dental · 11d
Cleared Apr 29, 1980
GAL-PUT CONTROLS, NORMAL&DEFICIENT
K800910 · JIX
Sigma Chemical Co.
Chemistry · 8d
Cleared Apr 28, 1980
ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
K800408 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT BONE MARROW BIOPSY ASPIRATION TRAY
K800409 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT BONE MARROW BIOPSY-ASPIRATION TRAY
K800410 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS
K800411 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW
K800412 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT SOFT TISSUE BIOPSY TRAY
K800414 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL
K800417 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT DISPOSABLE THIN NEEDLE ASPIRATION
K800418 · FSM
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 24, 1980
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.
K800147 · KRH
Usifroid
Cardiovascular · 93d
Cleared Apr 24, 1980
MEDSPEC OPERATIVE OPTHALMIC KIT
K800404 · HMP
Medi-Spec
General & Plastic Surgery · 58d
Cleared Apr 24, 1980
GEMENI IGM ASSAY
K800450 · DAO
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d