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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37369–37392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2014
BASE IT
K134022 · EJK
Spident Co., Ltd.
Dental · 163d
Cleared Jun 11, 2014
CONTRAST MODULATION SYSTEM
K140425 · DXT
Osprey Medical, Inc.
Cardiovascular · 112d
Cleared Jun 11, 2014
CELESTEION, PCA-9000A/2
K140651 · KPS
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Jun 11, 2014
FLEX ENDOSCOPIC INSTRUMENTS
K140662 · GCJ
Design Standards Corp.
General & Plastic Surgery · 89d
Cleared Jun 11, 2014
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
K140854 · ITX
Hitachi Aloka Medical, Ltd.
Radiology · 69d
Cleared Jun 11, 2014
MTA2.1 MATERIAL
K140955 · KIF
Avalon Biomed, Inc.
Dental · 58d
Cleared Jun 11, 2014
MAMMI
K140996 · KPS
General Equipment For Medical Imaging...
Radiology · 55d
Cleared Jun 11, 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 10, 2014
SPIROX INEX DEVICE
K132920 · NHB
Spirox, Inc.
Ear, Nose, Throat · 266d
Cleared Jun 10, 2014
QUADROSTARPROGREEN, QUADROSTARPROYELLOW
K133297 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 228d
Cleared Jun 10, 2014
CHESAPEAKE SPINAL SYSTEM
K133494 · OVD
K2m, Inc.
Orthopedic · 208d
Cleared Jun 10, 2014
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
K133770 · GAT
Anchor Innovation Medical (A.I.M.)
General & Plastic Surgery · 181d
Cleared Jun 10, 2014
ESTEMP IMPLANT, ESTEMP CLEAR
K134021 · EMA
Spident Co., Ltd.
Dental · 162d
Cleared Jun 10, 2014
HEARTNAVIGATOR RELEASE 2.0
K140138 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 139d
Cleared Jun 10, 2014
ORTHALIGN PLUS SYSTEM
K140331 · OLO
Orthalign, Inc.
Orthopedic · 120d
Cleared Jun 10, 2014
MASTERGRAFT PUTTY
K140374 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 116d
Cleared Jun 10, 2014
TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
K140521 · GEI
ArthroCare Corporation
General & Plastic Surgery · 98d
Cleared Jun 10, 2014
PCD 737A
K140642 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 90d
Cleared Jun 10, 2014
EMERGE EXTERNAL FIXATION SYSTEM
K140675 · KTT
Emerge Medical, Inc.
Orthopedic · 84d
Cleared Jun 10, 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
K140967 · FTL
Insightra Medical
General & Plastic Surgery · 57d
Cleared Jun 10, 2014
MASTERSL FEMORAL STEM
K140975 · LZO
Lima Corporate S.P.A.
Orthopedic · 55d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · JWY
Thermo Fisher Scientific
Microbiology · 55d
Cleared Jun 10, 2014
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 10, 2014
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON...
K141259 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 26d