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"
1129–1152 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 02, 1983
MILLER-ABBOTT TUBE
K830998 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · JZJ
Abbott Laboratories
Hematology · 380d
Cleared Apr 14, 1983
PCA PUMP
K830452 · FRN
Abbott Laboratories
General Hospital · 58d
Cleared Apr 12, 1983
TDX T-UPTAKE
K830912 · KHQ
Abbott Laboratories
Chemistry · 22d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · JSS
Abbott Laboratories
Microbiology · 32d
Cleared Apr 06, 1983
TDX THYROXINE
K830683 · KLI
Abbott Laboratories
Chemistry · 33d
Cleared Apr 05, 1983
FLUOROMETER, GENERAL USE
K830624 · KHO
Abbott Diagnostics
Toxicology · 36d
Cleared Mar 31, 1983
WINGED CATHETER
K830765 · FOZ
Abbott Laboratories
General Hospital · 21d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · FKX
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Mar 11, 1983
CAPD COLOR-GUARD SYSTEM PREPKIT
K830002 · FKY
Abbott Laboratories
Gastroenterology & Urology · 67d
Cleared Mar 10, 1983
TDX METHOTREXATE
K830398 · LAO
Abbott Laboratories
Chemistry · 31d
Cleared Mar 07, 1983
DOUBLE LUMEN SUBCLAVIAN CATHETER
K823135 · LFJ
Abbott Laboratories
Gastroenterology & Urology · 130d
Cleared Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
K823569 · GTZ
Abbott Laboratories
Chemistry · 88d
Cleared Feb 18, 1983
TDX N-ACETYLPROCAINAMIDE
K830206 · LAN
Abbott Laboratories
Chemistry · 28d
Cleared Feb 15, 1983
MS-2 BACTERIAL IDENTI. SYS
K830099 · JTO
Abbott Laboratories
Microbiology · 35d
Cleared Jan 17, 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · CAK
Abbott Laboratories
General Hospital · 14d
Cleared Dec 28, 1982
HEMATOLOGY ANALYZER
K823344 · GKL
Abbott Diagnostics
Hematology · 50d
Cleared Dec 15, 1982
POSITIVE I.D. SYSTEM
K823266 · JJQ
Abbott Laboratories
Microbiology · 43d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · FKX
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Oct 27, 1982
HISH EIA DIAGNOSTIC KIT
K822827 · JLW
Abbott Laboratories
Chemistry · 36d
Cleared Oct 26, 1982
FOLATE/B12 DUO-BEAD RADIOASSAY
K822241 · CEN
Abbott Laboratories
Chemistry · 91d
Cleared Oct 21, 1982
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · CFT
Abbott Laboratories
Chemistry · 37d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · FKX
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658 · FKX
Abbott Laboratories
Gastroenterology & Urology · 48d