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"
937–960 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · JXM
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · LCL
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
K880010 · DJG
Abbott Laboratories
Toxicology · 38d
Cleared Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · KPF
Abbott Laboratories
Gastroenterology & Urology · 119d
Cleared Jan 21, 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · CDT
Abbott Laboratories
Chemistry · 99d
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646 · LDJ
Abbott Laboratories
Chemistry · 35d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · LIQ
Abbott Laboratories
Microbiology · 45d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Abbott Laboratories
Chemistry · 68d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · DIO
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · DKZ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR OPIATES
K874485 · DJG
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · LCL
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483 · DIS
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944 · JFJ
Abbott Laboratories
Chemistry · 56d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · DIF
Abbott Laboratories
Toxicology · 103d
Cleared Sep 09, 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · GGK
Abbott Diagnostics
Hematology · 20d
Cleared Sep 09, 1987
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · GIF
Abbott Diagnostics
Hematology · 20d
Cleared Sep 08, 1987
MODEL 690 SPECTROPHOTOMETER
K873408 · JJQ
Abbott Diagnostics
Chemistry · 14d
Cleared Sep 02, 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · CGX
Abbott Laboratories
Chemistry · 15d
Cleared Aug 26, 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · KNT
Abbott Laboratories
Gastroenterology & Urology · 106d
Cleared Aug 25, 1987
ABBOTT A-GENT IRON REAGENT KIT
K873120 · CFM
Abbott Laboratories
Chemistry · 15d
Cleared Aug 21, 1987
VISION(R) TOTAL BILIRUBIN
K872487 · CIG
Abbott Laboratories
Chemistry · 59d