FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
2377–2400 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 21, 2006
MISSION COMPLETE
K060206 · JJY
Diamond Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429 · JJY
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Mar 13, 2006
FERRITIN CALIBRATOR SET, CATALOG NO. 8203
K053291 · JIT
Reference Diagnostics, Inc.
Chemistry · 108d
Cleared Mar 13, 2006
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
K051596 · NBC
Nanogen, Inc.
Chemistry · 270d
Cleared Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 14d
Cleared Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 16d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371 · JIT
Dade Behring, Inc.
Chemistry · 24d
Cleared Mar 09, 2006
DIMENSION IRON CALIBRATOR
K060266 · JIS
Dade Behring, Inc.
Chemistry · 36d
Cleared Mar 09, 2006
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
K053553 · DCF
Polymedco, Inc.
Chemistry · 79d
Cleared Mar 09, 2006
ACCUREX GLUCOSE TEST STRIP
K052207 · CGA
Incline Medical, LLC
Chemistry · 209d
Cleared Mar 09, 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 245d
Cleared Mar 08, 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · JIY
Dade Behring, Inc.
Chemistry · 35d
Cleared Mar 03, 2006
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531 · CEC
Dade Behring, Inc.
Chemistry · 74d
Cleared Mar 02, 2006
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE...
K050975 · MMI
Nano-Ditech Co.
Chemistry · 318d
Cleared Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA)...
K060420 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 12d
Cleared Mar 01, 2006
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
K053312 · NBW
Bioptik Technology, Inc.
Chemistry · 93d
Cleared Mar 01, 2006
MYSET PREGNANCY TEST
K053138 · LCX
Ani Biotech OY
Chemistry · 112d
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 17d
Cleared Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256 · CFR
Beckman Coulter, Inc.
Chemistry · 26d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · JLW
Dade Behring, Inc.
Chemistry · 46d
Cleared Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · NBW
Bionime Corporation
Chemistry · 54d
Cleared Feb 17, 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019 · LCX
Artron Laboratories, Inc.
Chemistry · 44d
Cleared Feb 17, 2006
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253 · KQO
Hemocue AB
Chemistry · 88d
Cleared Feb 16, 2006
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
K060133 · JJX
Inverness Medical Innovations, Inc.
Chemistry · 29d