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: Cleared only ×
175,468 results
94825–94848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1997
ELIAS ANA-HEP-2
K964385 · LJM
Elias U.S.A., Inc.
Immunology · 122d
Cleared Mar 06, 1997
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD...
K964609 · JBP
Array Medical, Inc.
Hematology · 108d
Cleared Mar 06, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
K964843 · JZH
Beckman Instruments, Inc.
Immunology · 93d
Cleared Mar 06, 1997
ANATOM 2000
K964890 · JAK
Analogic Corp.
Radiology · 90d
Cleared Mar 06, 1997
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
K964939 · BZC
Creative Biomedics, Inc.
Anesthesiology · 86d
Cleared Mar 06, 1997
SENTURA SURGICAL GLOVES
K964962 · KGO
Maxxim Medical
General Hospital · 85d
Cleared Mar 06, 1997
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
K964967 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Mar 06, 1997
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH...
K964980 · KGO
Maxxim Medical
General Hospital · 83d
Cleared Mar 06, 1997
COULTER AC.T SERIES ANALYZER
K964988 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Mar 06, 1997
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
K965055 · HET
Imagyn Medical, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 06, 1997
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
K965070 · QGH
Mecta Corp.
Neurology · 85d
Cleared Mar 06, 1997
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
K965078 · GWG
Neuro Navigational Corp.
Neurology · 77d
Cleared Mar 06, 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · DEW
Beckman Instruments, Inc.
Immunology · 76d
Cleared Mar 06, 1997
MEDICOM, TENS ELECTRODES
K965194 · GXY
Medicotest A/S
Neurology · 72d
Cleared Mar 06, 1997
CR PERFECT
K970087 · CGX
Chimera Research & Chemical, Inc.
Chemistry · 55d
Cleared Mar 06, 1997
LIPASE REAGENT SET (COLIPASE METHOD)
K970124 · CET
Teco Diagnostics
Chemistry · 51d
Cleared Mar 06, 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 44d
Cleared Mar 06, 1997
MEDLINE CIRCUMCISION TRAY
K970282 · HFX
Medline
Obstetrics & Gynecology · 41d
Cleared Mar 06, 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · MKJ
Contour Medical Technology, Inc.
Cardiovascular · 31d
Cleared Mar 06, 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424 · JHI
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 06, 1997
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
K970425 · LCX
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970452 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK PSA
K970458 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970459 · JJX
Boehringer Mannheim Corp.
Immunology · 28d