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
71689–71712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2003
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
K031783 · FPA
Intravascular Incorporated
General Hospital · 21d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jul 01, 2003
HL888RA
K031835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jun 30, 2003
ANTIMICROBIAL ALGINATE DRESSING
K024298 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 188d
Cleared Jun 30, 2003
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K024323 · MLO
Biomedical Systems Corp.
Cardiovascular · 186d
Cleared Jun 30, 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · ESW
Rusch Intl.
Gastroenterology & Urology · 129d
Cleared Jun 30, 2003
ASAP CYSTOSCOPE
K031141 · FAJ
Asap Endoscopic Products GmbH
Gastroenterology & Urology · 81d
Cleared Jun 30, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031382 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 60d
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · EKX
Lares Research, Inc.
Dental · 45d
Cleared Jun 30, 2003
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
K031754 · LYY
Pt. Mandiri Inti Buana
General Hospital · 91d
Cleared Jun 30, 2003
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
K031884 · IPF
Ryan Telemedicine
Physical Medicine · 12d
Cleared Jun 30, 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · LLZ
Medison Co., Ltd.
Radiology · 12d
Cleared Jun 27, 2003
SMISSON STABILIZATION SYSTEM
K021979 · KWQ
Smisson-Cartledge
Orthopedic · 375d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Ortho Tec, LLC
Orthopedic · 262d
Cleared Jun 27, 2003
RAPID IMF
K030605 · DYX
Zygomatics , Ltd.
Dental · 122d
Cleared Jun 27, 2003
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
K030682 · LYC
Bioform, Inc.
Dental · 114d
Cleared Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · DAP
Kamiya Biomedical Co.
Hematology · 114d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744 · MQP
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 27, 2003
WARTNER PRO
K030838 · GEH
Wartner Medical Products
General & Plastic Surgery · 102d
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · LSE
Panbio Limited
Microbiology · 101d
Cleared Jun 27, 2003
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
K031014 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 88d
Cleared Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
K031026 · KNS
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 88d