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
95617–95640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1996
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · KWQ
Depuy, Inc.
Orthopedic · 184d
Cleared Dec 27, 1996
UM-D3000/UM-D4000
K963985 · GEI
J.J. Consulting Services, Inc.
General & Plastic Surgery · 84d
Cleared Dec 27, 1996
FOUNDATION KNEE SYSTEM
K964008 · JWH
Encore Orthopedics, Inc.
Orthopedic · 81d
Cleared Dec 27, 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
K964150 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 72d
Cleared Dec 27, 1996
TRIMAX NAIL SYSTEM
K964163 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 71d
Cleared Dec 27, 1996
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · JDI
Exactech, Inc.
Orthopedic · 63d
Cleared Dec 26, 1996
ALBA HEALTH PAS WRAP SYSTEM
K961405 · JOW
Alba-Waldensian, Inc.
Cardiovascular · 259d
Cleared Dec 26, 1996
IMAGEN RESPIRATORY SCREEN
K962037 · GNW
Dako Diagnostics , Ltd.
Microbiology · 216d
Cleared Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
K962418 · CDQ
Stanbio Laboratory
Chemistry · 185d
Cleared Dec 26, 1996
STC AUTO-LYTE URINARY GLUCOSE ASSAY
K962435 · CFR
OraSure Technologies, Inc.
Chemistry · 185d
Cleared Dec 26, 1996
MODEL 5500 CEAS
K963938 · CHQ
Esa, Inc.
Chemistry · 86d
Cleared Dec 26, 1996
MIRACLE-EAR OR AUDIOTONE
K964669 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 24, 1996
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K960915 · GWG
Clarus Medical Systems, Inc.
Neurology · 293d
Cleared Dec 24, 1996
BRIO AUTOMATIC SAMPLINC UNIT
K961209 · JJF
Seac S.R.L.
Chemistry · 271d
Cleared Dec 24, 1996
HEMODIALYSIS INTRODUCER SET
K961780 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 230d
Cleared Dec 24, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · CKG
Nichols Institute Diagnostics
Chemistry · 175d
Cleared Dec 24, 1996
WAKO DIRECT HDL-C
K963847 · JIS
Wako Chemicals USA, Inc.
Chemistry · 90d
Cleared Dec 24, 1996
NEO-CARE DUAL LUMEN UMBILICAL CATHETER
K963972 · FOS
Klein-Baker Medical, Inc.
General Hospital · 82d
Cleared Dec 24, 1996
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
K964060 · FMF
Travenol Laboratories (Israel) , Ltd.
General Hospital · 76d
Cleared Dec 24, 1996
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · LBZ
Bayer Corp.
Chemistry · 70d
Cleared Dec 24, 1996
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
K964637 · JSM
Medical Packaging Corp.
Microbiology · 35d
Cleared Dec 23, 1996
VENTANA CEA PRIMARY ANTIBODY
K940242 · DFD
Ventana Medical Systems, Inc.
Immunology · 1069d
Cleared Dec 23, 1996
SI CONTROLLER MODEL SI 500
K960492 · BTA
I.C Medical, Inc.
General & Plastic Surgery · 325d
Cleared Dec 23, 1996
SIEMENS SERVO ULTRA NEBULIZER 345
K960854 · CAF
Pacesetter, Inc.
Anesthesiology · 297d