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"
1225–1248 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 16, 1979
ROTAZYME
K791746 · LFX
Abbott Laboratories
Microbiology · 67d
Cleared Nov 13, 1979
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · CGN
Abbott Laboratories
Chemistry · 18d
Cleared Nov 13, 1979
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K791928 · DHN
Keith E. Abbott
Immunology · 47d
Cleared Nov 13, 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · JLW
Abbott Laboratories
Chemistry · 64d
Cleared Oct 26, 1979
IV EXTENSION SET SL
K791930 · FPA
Abbott Laboratories
General Hospital · 29d
Cleared Oct 26, 1979
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · KPE
Abbott Laboratories
General Hospital · 46d
Cleared Oct 17, 1979
A-GENT GLYCOSPEC
K791642 · LCP
Abbott Laboratories
Hematology · 55d
Cleared Oct 11, 1979
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · DTL
Abbott Laboratories
Cardiovascular · 16d
Cleared Oct 01, 1979
ADDITIVE HINGE CAP
K791796 · KPE
Abbott Laboratories
Chemistry · 17d
Cleared Sep 17, 1979
STERILE WATER FOR RESPIRATORY THERAPY
K791683 · BTT
Abbott Laboratories
Anesthesiology · 20d
Cleared Sep 12, 1979
FLEXIFLO ENTERAL PUMP SET
K791531 · BSS
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Sep 12, 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · FRN
Abbott Laboratories
General Hospital · 33d
Cleared Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · DJB
Abbott Laboratories
Microbiology · 263d
Cleared Aug 16, 1979
RUBAZYME
K790976 · GOL
Abbott Laboratories
Microbiology · 85d
Cleared Aug 10, 1979
A-GENT QUANTICHROM T4 11A
K790848 · KLI
Abbott Laboratories
Chemistry · 99d
Cleared Jun 15, 1979
NUCLEAR SAMPLE READER
K790905 · JJJ
Abbott Laboratories
Toxicology · 35d
Cleared May 14, 1979
DRESSING, ENVIRON WOUND
K782008 · KMF
Abbott Laboratories
General & Plastic Surgery · 164d
Cleared May 08, 1979
OXYGEN HUMIDIFIER KIT
K790731 · BTT
Abbott Laboratories
Anesthesiology · 22d
Cleared May 03, 1979
THE ABBOTT EXECUTIVE
K790543 · JQP
Abbott Laboratories
Chemistry · 42d
Cleared Apr 26, 1979
DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
K790297 · JTA
Abbott Laboratories
Microbiology · 76d
Cleared Apr 23, 1979
GONO-CELL
K782013 · JSX
Abbott Laboratories
Microbiology · 139d
Cleared Apr 04, 1979
A-GENT-HDL REAGENT
K790329 · LBR
Abbott Laboratories
Immunology · 47d
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · CZP
Abbott Laboratories
Chemistry · 26d
Cleared Feb 27, 1979
PREAMPLIFIER MODULE, EKG RESPIRATION
K790304 · BZQ
Abbott Medical Electronics Co.
Anesthesiology · 14d