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
42865–42888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2012
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264 · HBE
Medtronic Surgical Technologies
Neurology · 123d
Cleared Aug 27, 2012
PICIS WEIGHT BASED DOSE CONVERTER
K121542 · NDC
Picis, Inc.
General Hospital · 95d
Cleared Aug 27, 2012
ACE MAGNESIUM REGENT
K122302 · JGJ
Alfa Wassermann Diagnostics...
Chemistry · 26d
Cleared Aug 24, 2012
ARJORAD STERILE WRAP
K110954 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 507d
Cleared Aug 24, 2012
RANDOX OPIATES ASSAY
K113747 · DJG
Randox Laboratories Limited
Chemistry · 248d
Cleared Aug 24, 2012
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · CFF
Grifols USA, LLC
Immunology · 218d
Cleared Aug 24, 2012
ELEVANCE
K120239 · EIA
Midmark
Dental · 211d
Cleared Aug 24, 2012
ZIMMER TRABECULAR METAL TOTAL ANKLE
K120906 · HSN
Zimmer, Inc.
Orthopedic · 151d
Cleared Aug 24, 2012
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE,...
K121103 · NKB
Ldr Spine USA, Inc.
Orthopedic · 135d
Cleared Aug 24, 2012
AIXPLORER
K121329 · IYN
Supersonic Imagine
Radiology · 114d
Cleared Aug 24, 2012
NUVASIVE POLYAXIAL SPINAL SCREWS
K121619 · NKB
Nuvasive, Inc.
Orthopedic · 84d
Cleared Aug 24, 2012
INWAVE
K121820 · KPI
Zynex Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 24, 2012
PHANTOM PLUS CERAMIC CAGE SYSTEM
K121892 · MAX
Amedica Corp.
Orthopedic · 56d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · JJX
Roche Diagnostics
Microbiology · 56d
Cleared Aug 24, 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K122254 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 23, 2012
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
K111603 · DYB
Ep Dynamics, Inc.
Cardiovascular · 442d
Cleared Aug 23, 2012
FREEDOM INGUINAL HERNIA IMPLANT
K113552 · FTL
Insightra Medical
General & Plastic Surgery · 266d
Cleared Aug 23, 2012
(MULTIPLE) DIGITAL THERMOMETER
K120004 · FLL
China Shenyang Med-Land Imp/Exp...
General Hospital · 233d
Cleared Aug 23, 2012
TRANS1 INTERBODY FUSION SYSTEM
K120991 · MAX
Trans1 Incorporated
Orthopedic · 143d
Cleared Aug 23, 2012
NMI PICC III
K121089 · LJS
Navilyst Medical, Inc.
General Hospital · 135d
Cleared Aug 23, 2012
AVT NATURASOFT
K121324 · LPL
Advanced Vision Technologies
Ophthalmic · 113d
Cleared Aug 23, 2012
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502 · MQN
Synthes, Inc.
Dental · 94d
Cleared Aug 23, 2012
AMPLATZER TORQVUE FX
K121611 · DQY
Aga Medical Corporation
Cardiovascular · 83d
Cleared Aug 23, 2012
ETCHONIA ZERONA ARMS
K121690 · OLI
Erchonia Corporation
General & Plastic Surgery · 77d