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

Filters: Cleared only ×
174,955 results
114049–114072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1993
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
K925916 · LQL
Biomerieux Vitek, Inc.
Chemistry · 120d
Cleared Mar 23, 1993
ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
K926421 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Mar 23, 1993
S/2(TM) STOPCOCK
K926423 · FGB
Psi Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 23, 1993
4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
K926433 · LYK
Baxter Edwards
Cardiovascular · 90d
Cleared Mar 23, 1993
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
K930130 · LLL
Biowhittaker Molecular Applications,...
Immunology · 70d
Cleared Mar 23, 1993
CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS
K930325 · KIR
Proteins Intl., Inc.
Pathology · 60d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG # 02-241
K930364 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241
K930365 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
16 X 25 MM TEST TUBE, CATALOG #01-461
K930366 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321
K930367 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-321
K930368 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25CM, 75CM, 150CM, FLASK, CATALOG #03-311
K930369 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIALS, CATALOG #02-311
K930370 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-321
K930371 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-311
K930372 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-111
K930373 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111
K930374 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-211
K930375 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-211
K930376 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461
K930377 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441
K930378 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-281
K930379 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-261
K930380 · KIR
Proteins Intl., Inc.
Pathology · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-441
K930381 · KIR
Proteins Intl., Inc.
Pathology · 56d