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"
1249–1272 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 01, 1979
A-GENT CK-MB
K782015 · JHW
Abbott Laboratories
Chemistry · 58d
Cleared Jan 10, 1979
ANALYZER ABA-200
K782014 · JJE
Abbott Laboratories
Chemistry · 36d
Cleared Dec 04, 1978
PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS
K781000 · CEO
Abbott Laboratories
Chemistry · 172d
Cleared Nov 22, 1978
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · CJM
Abbott Laboratories
Chemistry · 84d
Cleared Oct 17, 1978
PRESSURE INFUSION CUFF
K781556 · DXN
Abbott Laboratories
Cardiovascular · 36d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427 · JSS
Abbott Laboratories
Microbiology · 36d
Cleared Sep 20, 1978
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · JXA
Abbott Laboratories
Microbiology · 43d
Cleared Sep 07, 1978
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · KMF
Abbott Laboratories
General & Plastic Surgery · 24d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423 · JIT
Abbott Laboratories
Chemistry · 14d
Cleared Jul 07, 1978
SUTURELESS SKIN CLOSURE
K780565 · FPX
Abbott Laboratories
General & Plastic Surgery · 92d
Cleared Jun 30, 1978
Y-TYPE BLOOD SET
K780880 · KDC
Abbott Laboratories
General & Plastic Surgery · 31d
Cleared May 03, 1978
CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.
K780372
Abbott Laboratories
Chemistry · 56d
Cleared Apr 19, 1978
HYDRON BURN DISPOSABLE DISPENSER SET
K780616 · KMF
Abbott Laboratories
General & Plastic Surgery · 6d
Cleared Mar 22, 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · JJE
Syva Co.
Immunology · 12d
Cleared Feb 21, 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · FOZ
Abbott Laboratories
General Hospital · 32d
Cleared Feb 03, 1978
HTSH RIA
K780122 · KHO
Abbott Laboratories
Toxicology · 11d
Cleared Jan 26, 1978
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · FPB
Abbott Laboratories
General Hospital · 41d
Cleared Jan 03, 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · FPB
Abbott Laboratories
General Hospital · 78d
Cleared Dec 20, 1977
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · JJQ
Abbott Laboratories
Immunology · 70d
Cleared Dec 08, 1977
LIFECARE I.V. PUMP - MODEL III
K772094 · FRN
Abbott Laboratories
General Hospital · 31d
Cleared Nov 16, 1977
IN-LINE BURETTE SET
K772036 · FPA
Abbott Laboratories
Hematology · 20d
Cleared Nov 09, 1977
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669 · JBQ
Abbott Laboratories
Hematology · 69d
Cleared Nov 03, 1977
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · DXG
Abbott Laboratories
Cardiovascular · 15d
Cleared Sep 28, 1977
PRIMARY PIGGYBACK VENOSET W/ FILTER
K771594 · FPB
Abbott Laboratories
General Hospital · 40d