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"
1177–1200 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · GKL
Abbott Diagnostics
Hematology · 173d
Cleared May 29, 1981
TOX TM ANALYZER
K811263 · JQZ
Abbott Laboratories
Immunology · 23d
Cleared May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · FPA
Abbott Laboratories
General Hospital · 121d
Cleared May 27, 1981
NITROGLYCERINE IV SET
K810317 · FPA
Abbott Laboratories
General Hospital · 110d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Abbott Laboratories
Immunology · 41d
Cleared Apr 29, 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 15d
Cleared Apr 21, 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · CAK
Abbott Laboratories
Hematology · 22d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794 · CDQ
Abbott Laboratories
Chemistry · 9d
Cleared Mar 17, 1981
QUANTICHECK CONTROL PLASMA
K803081 · GGQ
Abbott Laboratories
Chemistry · 102d
Cleared Feb 26, 1981
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · CGJ
Abbott Laboratories
Chemistry · 13d
Cleared Feb 10, 1981
MODEL AM 721 ELECTROLYTE ANALYZER
K810135 · JGS
Abbott Diagnostics
Chemistry · 20d
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jan 28, 1981
CYBREX VALPROIC ACID
K803236 · LEG
Abbott Laboratories
Toxicology · 36d
Cleared Jan 21, 1981
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · GKZ
Abbott Laboratories
Microbiology · 33d
Cleared Jan 15, 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · CDP
Abbott Laboratories
Chemistry · 22d
Cleared Jan 06, 1981
REGULATOR VENOSET W/0.22 MICRON IVEX
K810029
Abbott Laboratories
General Hospital
Cleared Dec 22, 1980
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075 · DON
Abbott Laboratories
Toxicology · 17d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902 · KLT
Abbott Laboratories
Immunology · 32d
Cleared Dec 01, 1980
MS-2 IDENTIFICATION SYSTEM
K802309 · JXB
Abbott Laboratories
Microbiology · 69d
Cleared Nov 24, 1980
CYBREX TOBRAMYCIN
K802668 · LCR
Abbott Laboratories
Toxicology · 28d
Cleared Nov 12, 1980
CYBREX AMIKACIN
K802669 · KLQ
Abbott Laboratories
Chemistry · 16d
Cleared Nov 12, 1980
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · KHO
Abbott Laboratories
Pathology · 23d
Cleared Oct 31, 1980
CYBREX LIDOCAINE
K802131 · KLR
Abbott Laboratories
Toxicology · 57d
Cleared Oct 10, 1980
INPERSOL-CAPD ADMINISTRATION SET
K801881 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 64d