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"
1105–1128 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 27, 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · KLS
Abbott Laboratories
Toxicology · 57d
Cleared Dec 22, 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741 · FPA
Abbott Laboratories
General Hospital · 57d
Cleared Nov 14, 1983
TDX THEOPHYLLINE
K833070 · LER
Abbott Laboratories
Toxicology · 67d
Cleared Nov 07, 1983
TDX GLUCOSE
K833069 · CGA
Abbott Laboratories
Toxicology · 60d
Cleared Oct 31, 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · KNT
Abbott Laboratories
Gastroenterology & Urology · 60d
Cleared Oct 27, 1983
YBBOTT CMV TOTAL AB EIA
K832221 · LFZ
Abbott Laboratories
Microbiology · 111d
Cleared Oct 14, 1983
ABBOTT IGE EIA
K832360 · DGC
Abbott Laboratories
Chemistry · 88d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962 · LJC
Abbott Laboratories
Chemistry · 110d
Cleared Sep 29, 1983
ABBOTT GLOBE HOLDER
K832911 · HJO
Miami Eye Technology, Inc.
Ophthalmic · 31d
Cleared Sep 29, 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775 · LCP
Abbott Laboratories
Chemistry · 44d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Abbott Diagnostics
Hematology · 53d
Cleared Sep 26, 1983
QUANTUM II YEAST IDENT. SYSTEM
K832406 · JXC
Abbott Laboratories
Microbiology · 67d
Cleared Sep 12, 1983
A-GENT CARBAMAZEPINE
K832631 · KLT
Abbott Laboratories
Toxicology · 39d
Cleared Sep 12, 1983
A-GENT PHENOBARBITAL
K832457 · DLZ
Abbott Laboratories
Toxicology · 48d
Cleared Sep 12, 1983
LIFECARE MICRO PUMP
K832289 · FRN
Abbott Laboratories
General Hospital · 61d
Cleared Sep 01, 1983
A-GENT PHERYTOIN
K832419 · DIP
Abbott Laboratories
Toxicology · 41d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595 · DWP
Abbott Laboratories
Cardiovascular · 29d
Cleared Aug 24, 1983
SPECTROPHOTOMETER #390
K832206 · JJQ
Abbott Diagnostics
Toxicology · 48d
Cleared Aug 12, 1983
VENIPUNCTURE VALVE
K832123 · FPA
Abbott Laboratories
General Hospital · 43d
Cleared Aug 12, 1983
PROMINJET PUMP
K832120 · FRN
Abbott Laboratories
General Hospital · 43d
Cleared Jul 28, 1983
PRO QUANTUM
K831249 · JQW
Abbott Laboratories
Chemistry · 101d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038 · GKL
Abbott Diagnostics
Hematology · 24d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368 · GKL
Abbott Diagnostics
Hematology · 83d
Cleared Jun 03, 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · FRN
Abbott Laboratories
General Hospital · 51d