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"
577–600 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 15, 1997
AXSYM CA 15-3
K963926 · MOI
Abbott Laboratories
Immunology · 350d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · MJZ
Abbott Diagnostics
Microbiology · 76d
Cleared Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · GKZ
Abbott Laboratories
Hematology · 137d
Cleared Jul 03, 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · FRN
Abbott Mfg., Inc.
General Hospital · 184d
Cleared Jun 27, 1997
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
K971293 · FPA
Abbott Mfg., Inc.
General Hospital · 81d
Cleared Jun 24, 1997
ABBOTT AXSYM FOLATE
K972232 · CGN
Abbott Laboratories
Chemistry · 8d
Cleared Mar 24, 1997
AXSYM B12
K965186 · CDD
Abbott Laboratories
Chemistry · 90d
Cleared Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · LFZ
Abbott Laboratories
Microbiology · 579d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661 · DXG
Abbott Laboratories
Cardiovascular · 308d
Cleared Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
K970527 · JJX
Abbott Laboratories
Chemistry · 20d
Cleared Feb 26, 1997
LIFESHIELD BLUNT CANNULA
K963351 · FMI
Abbott Laboratories
General Hospital · 184d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · JHI
Abbott Laboratories
Chemistry · 62d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552 · FOZ
Abbott Laboratories
General Hospital · 294d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · LCX
Abbott Laboratories
Chemistry · 15d
Cleared Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 18, 1996
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · GKZ
Abbott Diagnostics
Hematology · 186d
Cleared Oct 08, 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955715 · GKZ
Abbott Laboratories
Hematology · 313d
Cleared Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · KNT
Abbott Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · LFX
Abbott Laboratories
Microbiology · 392d
Cleared Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · LFZ
Abbott Laboratories
Microbiology · 396d
Cleared Sep 17, 1996
RV PACING LEAD
K962467 · LDF
Abbott Laboratories
Cardiovascular · 84d
Cleared Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · LFM
Abbott Laboratories
Toxicology · 46d
Cleared Aug 23, 1996
AXSYM TOXO IGM
K954576 · LGD
Abbott Laboratories
Microbiology · 326d