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

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176,076 results
152377–152400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1984
COAT-A-COUNT DHEA RIA KIT
K842606 · JKC
Diagnostic Products Corp.
Chemistry · 43d
Cleared Aug 17, 1984
ACCESS. TO INTERAVACULAR ADMIN. SET
K842657 · FPA
Tanner Corp.
General Hospital · 38d
Cleared Aug 17, 1984
SAFRANIN STAIN
K842734 · HZS
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
PAP STAIN, OG-6
K842736 · HZJ
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
PAP STAIN EA-50
K842738 · HZJ
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
DELAFIELD HEMATOXYLIN STAIN
K842740 · HYJ
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
K842746 · KSQ
R&D Systems, Inc.
Hematology · 35d
Cleared Aug 17, 1984
OSMOTIC PRESSURE AUTO & STAT OM-6010
K842750 · JJM
Kyoto Diagnostics, Inc.
Chemistry · 35d
Cleared Aug 17, 1984
OMNI-TRACT SURGICAL RETRACTOR SYS
K842762 · GAD
Minnesota Scientific, Inc.
General & Plastic Surgery · 32d
Cleared Aug 17, 1984
SILIMED BREAST FORM
K842765 · GBI
Sil-Med Corp.
General & Plastic Surgery · 32d
Cleared Aug 17, 1984
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB
K842775 · KIT
Sigma Chemical Co.
Microbiology · 32d
Cleared Aug 17, 1984
PHYSIOLOGICAL ANALYZER CM-710
K842782 · BZM
Cybermedic, Inc.
Anesthesiology · 31d
Cleared Aug 17, 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · CIG
Technicon Instruments Corp.
Chemistry · 30d
Cleared Aug 17, 1984
DENTI-D RUBBER DAM
K842844 · EIE
Fema Corp.
Dental · 28d
Cleared Aug 17, 1984
SEWON DENTAL FLOSS FOLDER
K842846 · JES
Sewon Industry
Dental · 28d
Cleared Aug 17, 1984
TRIPLE SUGAR IRON
K842850 · JSH
Anarobe Systems
Microbiology · 28d
Cleared Aug 17, 1984
MUELLER HINTON BROTH
K842854 · JTZ
Anarobe Systems
Microbiology · 28d
Cleared Aug 17, 1984
RADOVAN TISSUE EXPANDER
K842883 · LCJ
Mentor Corp.
General & Plastic Surgery · 25d
Cleared Aug 17, 1984
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · EWL
American V. Mueller
Ear, Nose, Throat · 25d
Cleared Aug 17, 1984
CURITY I.V. START KIT
K842898 · LRS
The Kendal Co.
General & Plastic Surgery · 25d
Cleared Aug 17, 1984
BOUNDARY SINGLE-USE OR GOWN
K842958 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 21d
Cleared Aug 17, 1984
RHYS-DAVIES EXSANGUINATOR
K842963 · KCY
Woodville Polymer Engineering, Ltd.
General & Plastic Surgery · 21d
Cleared Aug 17, 1984
BROWNIE BOOTH BB1
K842975 · FTC
Weingart, Inc.
General & Plastic Surgery · 18d
Cleared Aug 17, 1984
GRASSHOPPER - RETRACTOR
K842992 · GAD
Norton Texas Medical Products
General & Plastic Surgery · 18d