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"
865–888 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 17, 1989
LIFECARE MICRO PUMP
K883645 · FRN
Abbott Laboratories
General Hospital · 357d
Cleared Aug 15, 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · JFJ
Abbott Laboratories
Chemistry · 161d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Abbott Laboratories
Hematology · 63d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776 · JJE
Abbott Laboratories
Chemistry · 73d
Cleared Jul 28, 1989
LIFECARE 75 CONTROLLER
K893487 · LDR
Abbott Laboratories
General Hospital · 85d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Abbott Laboratories
Microbiology · 70d
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · LJC
Abbott Laboratories
Microbiology · 57d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650 · DIS
Abbott Laboratories
Chemistry · 34d
Cleared Apr 19, 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Apr 18, 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ
Abbott Diagnostics
Hematology · 77d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · CKA
Abbott Laboratories
Chemistry · 59d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Abbott Laboratories
Hematology · 60d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · CJE
Abbott Laboratories
Chemistry · 50d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · CEP
Abbott Laboratories
Chemistry · 51d
Cleared Mar 17, 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · GCX
Abbott Laboratories
General Hospital · 88d
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421 · JZG
Abbott Laboratories
Immunology · 42d
Cleared Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · FPA
Abbott Laboratories
General Hospital · 151d
Cleared Feb 28, 1989
LIFECARE MICRO PUMP
K883796 · FRN
Abbott Laboratories
General Hospital · 174d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · CGJ
Abbott Laboratories
Chemistry · 28d