FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
457–480 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 22, 1999
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...
K994039 · FRN
Abbott Laboratories
General Hospital · 23d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · GKZ
Abbott Laboratories
Hematology · 64d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d
Cleared May 19, 1999
ACP
K991010 · CKB
Abbott Diagnostics Mfg., Inc.
Chemistry · 54d
Cleared May 13, 1999
ACCLAIM INFUSION PUMP
K991501 · FRN
Abbott Laboratories
General Hospital · 14d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774 · DHX
Abbott Laboratories
Immunology · 63d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · JJY
Bio-Rad
Chemistry · 62d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · DHR
Bio-Rad
Immunology · 43d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
K990394 · JJY
Bio-Rad
Chemistry · 37d
Cleared Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
K990391 · JJY
Bio-Rad
Chemistry · 34d
Cleared Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
K990282 · JJY
Bio-Rad
Chemistry · 39d
Cleared Mar 08, 1999
RF
K990035 · DHR
Abbott Laboratories
Immunology · 61d
Cleared Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · LCX
Abbott Laboratories
Chemistry · 14d
Cleared Feb 16, 1999
CK
K983070 · CGS
Abbott Laboratories
Chemistry · 167d