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"
601–624 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 May 02, 1996
ABBOTT CELL-DYN 3500R SYSTEM
K960427 · GKZ
Sequoia Turner Corp.
Hematology · 94d
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
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · MKZ
Abbott Laboratories
Microbiology · 802d
Cleared Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
K953761 · LFH
Abbott Laboratories
Toxicology · 103d
Cleared Nov 13, 1995
AXSYM METHADONE
K953499 · DJR
Abbott Laboratories
Toxicology · 110d
Cleared Oct 26, 1995
AXSYM PHENCYCLIDINE II
K953534 · LCM
Abbott Laboratories
Toxicology · 91d
Cleared Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Oct 19, 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · GKZ
Abbott Laboratories
Hematology · 248d
Cleared Oct 17, 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · FRN
Abbott Laboratories
General Hospital · 77d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · DKZ
Abbott Laboratories
Toxicology · 95d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029 · JHI
Abbott Laboratories
Chemistry · 38d
Cleared Oct 03, 1995
ABBOTT IMX PROLACTIN(MODIFICATION)
K953656 · CFT
Abbott Mfg., Inc.
Chemistry · 77d