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"
841–864 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 17, 1989
VISION PHENYTOIN
K896074 · DIP
Abbott Laboratories
Chemistry · 29d
Cleared Nov 15, 1989
EPI-CATH(TM) EPIDURAL CATHETER
K895204 · BSO
Abbott Laboratories
Anesthesiology · 90d
Cleared Nov 13, 1989
ABBOTT IMX IGE
K895914 · DGC
Abbott Laboratories
Immunology · 34d
Cleared Nov 13, 1989
TDX(R) LITES(TM) LITHIUM
K894328 · JIH
Abbott Laboratories
Chemistry · 122d
Cleared Nov 01, 1989
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
K893766 · MAJ
Abbott Laboratories
General Hospital · 166d
Cleared Oct 31, 1989
ABBOTT TDX TOTAL T3 PLUS
K894238 · CDP
Abbott Laboratories
Chemistry · 132d
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · CFR
Abbott Laboratories
Chemistry · 78d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · CHH
Abbott Laboratories
Chemistry · 53d
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222 · JJE
Abbott Laboratories
Toxicology · 101d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182 · JHI
Abbott Laboratories
Chemistry · 102d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · DKZ
Abbott Laboratories
Toxicology · 38d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · CIC
Abbott Laboratories
Chemistry · 70d
Cleared Sep 13, 1989
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · CIT
Abbott Laboratories
Chemistry · 89d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Aug 25, 1989
ADX COCAINE METABOLITE
K890788 · DIO
Abbott Laboratories
Toxicology · 191d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743 · DIC
Abbott Laboratories
Chemistry · 193d
Cleared Aug 25, 1989
ADX CANNABINOIDS
K890693 · LDJ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · DKZ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691 · JXM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690 · DIS
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM OPIATES
K890689 · DGJ
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688 · LCM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 21, 1989
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · JQW
Abbott Laboratories
Chemistry · 74d
Cleared Aug 17, 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · GCX
Abbott Laboratories
General Hospital · 92d