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

1,305 results for "Abbott"
913–936 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · GQG
Abbott Laboratories
Microbiology · 22d
Cleared Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · GEX
Abbott Laboratories
General & Plastic Surgery · 165d
Cleared Jun 13, 1988
VENOVALVE(TM)
K881234 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · CFJ
Abbott Laboratories
Chemistry · 55d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029 · JIN
Abbott Laboratories
Chemistry · 172d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · DYG
Abbott Laboratories
Cardiovascular · 208d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469 · LJC
Abbott Laboratories
Microbiology · 110d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Abbott Laboratories
Microbiology · 296d
Cleared May 11, 1988
IMX FERRITIN
K881345 · DGD
Abbott Laboratories
Immunology · 42d
Cleared May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · LIQ
Abbott Laboratories
Microbiology · 66d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Abbott Laboratories
Microbiology · 206d
Cleared Apr 21, 1988
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
K881242 · GJZ
Abbott Diagnostics
Hematology · 36d
Cleared Apr 21, 1988
TDX (R) AMPHETAMINE CLASS
K874770 · DKZ
Abbott Laboratories
Toxicology · 154d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087 · CDP
Abbott Laboratories
Chemistry · 97d
Cleared Apr 05, 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · CIG
Abbott Laboratories
Chemistry · 41d
Cleared Apr 05, 1988
ABBOTT IMX HTSH
K880086 · JLW
Abbott Laboratories
Chemistry · 84d
Cleared Mar 31, 1988
CELL-DYN ISOTONIC DILUENT
K881130 · GIF
Abbott Diagnostics
Hematology · 15d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070 · JHI
Abbott Laboratories
Chemistry · 72d
Cleared Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Abbott Laboratories
Immunology · 82d
Cleared Mar 16, 1988
VISION(R) THYROXINE (T4)
K880662 · KLI
Abbott Laboratories
Chemistry · 28d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · DIO
Abbott Laboratories
Toxicology · 67d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · LDJ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · DKZ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · DIS
Abbott Laboratories
Toxicology · 57d