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

901 results for "Abbott Laboratories"
265–288 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · FPA
Abbott Laboratories
General Hospital · 267d
Cleared May 20, 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955673 · GKZ
Abbott Laboratories
Hematology · 196d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · LFX
Abbott Laboratories
Microbiology · 242d
Cleared May 09, 1996
AXSYM VANCOMYCIN II
K955851 · LEH
Abbott Laboratories
Toxicology · 134d
Cleared May 06, 1996
SNAPDOSE DEVICE
K955410 · FPA
Abbott Laboratories
General Hospital · 161d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · LSL
Abbott Laboratories
Microbiology · 881d
Cleared Apr 24, 1996
AXSYM N-ACETYLPROCAINAMIDE
K955422 · LAN
Abbott Laboratories
Toxicology · 148d
Cleared Apr 02, 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · LAR
Abbott Laboratories
Toxicology · 126d
Cleared Mar 07, 1996
AXSYM PROGESTERONE
K955025 · JLS
Abbott Laboratories
Chemistry · 126d
Cleared Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · GTZ
Abbott Laboratories
Microbiology · 220d
Cleared Jan 18, 1996
ABBOTT XL3M INFUSION PUMP
K952799 · FRN
Abbott Laboratories
General Hospital · 213d
Cleared Dec 29, 1995
AXSYM DIGITOXIN
K954420 · LFM
Abbott Laboratories
Toxicology · 99d
Cleared Dec 13, 1995
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K953731 · FRN
Abbott Laboratories
General Hospital · 127d