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
95113–95136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 23, 1996
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · KPS
Toshiba Medical Systems
Radiology · 290d
Cleared Dec 23, 1996
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT...
K960982 · FMI
Sherwood Medical Co.
General Hospital · 287d
Cleared Dec 23, 1996
H.A.M. APPLICATOR
K961601 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 242d
Cleared Dec 23, 1996
ULTRAMIX
K962093 · ITX
Sonotech, Inc.
Radiology · 208d
Cleared Dec 23, 1996
FLEXART V3.1 SOFTWARE
K962138 · LNH
Toshiba America Mri, Inc.
Radiology · 203d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Dec 23, 1996
ECOLOTION TRANSMISSION AND MASSAGE LOTION
K962840 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 168d
Cleared Dec 23, 1996
PHARMACIA CAP SYSTEM RAST FEIA
K962976 · DHB
Pharmacia & Upjohn Co.
Immunology · 145d
Cleared Dec 23, 1996
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K963111 · GGW
Chromogenix AB
Hematology · 133d