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"
1201–1224 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 20, 1980
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · DBF
Abbott Laboratories
Immunology · 29d
Cleared Aug 12, 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · FRN
Abbott Laboratories
General Hospital · 53d
Cleared Aug 12, 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 109d
Cleared Jul 21, 1980
CYBREX THEOPHYLLINE
K801567
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX PHENOBARBITAL
K801566
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX PHENYTOIN
K801565
Abbott Laboratories
Toxicology · 13d
Cleared Jul 08, 1980
ABBY II PATIENT MONITOR OR VITAL SIGNS M
K801515 · DRT
Abbott Medical Electronics Co.
Cardiovascular · 8d
Cleared Jun 20, 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · KHQ
Abbott Laboratories
Chemistry · 60d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · GGW
Abbott Laboratories
Hematology · 64d
Cleared May 30, 1980
A-GENT QUANTICHROM THROMBIGEN-E
K800656 · GGQ
Abbott Laboratories
Hematology · 66d
Cleared May 23, 1980
CYBREX GENTAMICIN
K801084 · LCQ
Abbott Laboratories
Toxicology · 16d
Cleared Apr 04, 1980
ADD OF RETICULOCYTE COUNT/CAPABILITIES
K800533 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Mar 20, 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
K800137 · FPA
Abbott Laboratories
General Hospital · 59d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%
K800429 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/CYSTEINE AND
K800428 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT
K800427 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST
K800426 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 10, 1980
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
K800295 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Mar 10, 1980
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
K800294 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Feb 26, 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · FMG
Abbott Laboratories
General Hospital · 18d
Cleared Jan 24, 1980
NEBULIZER TUBING SET
K800083 · CAF
Abbott Laboratories
Anesthesiology · 10d
Cleared Jan 24, 1980
VENTILATOR SET
K800056 · BTT
Abbott Laboratories
Anesthesiology · 14d
Cleared Jan 16, 1980
VENTED I.V. SET
K792228 · FPA
Abbott Laboratories
General Hospital · 72d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · CDX
Abbott Laboratories
Immunology · 27d