FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
577–600 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Aug 16, 1996
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · LGD
Abbott Laboratories
Microbiology · 319d
Cleared Jul 16, 1996
IMX RUBELLA IGG
K951541 · LFX
Abbott Laboratories
Microbiology · 470d
Cleared Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805 · FOZ
Abbott Laboratories
General Hospital · 325d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...
K960183 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054 · LJC
Abbott Laboratories
Microbiology · 891d
Cleared May 29, 1996
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · LHI
Abbott Laboratories
General Hospital · 148d