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"
337–360 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 18, 1994
AXSYM TOBRAMYCIN
K941614 · LFW
Abbott Laboratories
Toxicology · 136d
Cleared Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · JLW
Abbott Laboratories
Chemistry · 77d
Cleared Aug 16, 1994
AXSYM VALPROIC ACID
K941615 · LEG
Abbott Laboratories
Toxicology · 134d
Cleared Aug 03, 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · FPB
Abbott Laboratories
General Hospital · 121d
Cleared Jul 29, 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
K934513 · FPA
Abbott Laboratories
General Hospital · 317d
Cleared Jul 13, 1994
PROVIDER ANNE INFUSER
K922702 · FRN
Abbott Laboratories
General Hospital · 768d
Cleared Jun 21, 1994
AXSYM(TM) QUINIDINE
K940682 · LGI
Abbott Laboratories
Chemistry · 131d
Cleared Jun 21, 1994
AXSYM PHENOBARBITAL
K940596 · LGQ
Abbott Laboratories
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM VANCOMYCIN
K940595 · LEH
Abbott Laboratories
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM CK-MB
K935924 · JHW
Abbott Laboratories
Chemistry · 190d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847 · DBF
Abbott Laboratories
Immunology · 195d
Cleared Jun 21, 1994
AXSYM PROLACTIN
K935675 · CFT
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673 · JHI
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · CGJ
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611 · JJX
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM PHENYTOIN ASSAY
K935375 · LGR
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM CARBAMAZEPHINE
K935374 · KLT
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373 · KLS
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · CEC
Abbott Laboratories
Chemistry · 272d
Cleared Jun 21, 1994
AXSYM TOTAL T3
K934517 · CDP
Abbott Laboratories
Toxicology · 274d
Cleared Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · JLW
Abbott Laboratories
Chemistry · 284d
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384 · CDX
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM(TM) T-UPTAKE
K934312 · KHQ
Abbott Laboratories
Chemistry · 293d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329 · DQO
Abbott Laboratories
Cardiovascular · 35d