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
40153–40176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 33d
Cleared Jul 23, 2013
ULTRAEXTEND USWS-900A V2.1 AND V3.1
K131822 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Jul 23, 2013
ESIE APPS SUITE
K132062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 22, 2013
MR CONDITIONAL PRESSON ELECTRODE
K130220 · GXZ
Rhythmlink International, LLC
Neurology · 174d
Cleared Jul 22, 2013
RHYTHMIA MAPPING SYSTEM
K130750 · DQK
Rhythmia Medical, Inc.
Cardiovascular · 125d
Cleared Jul 22, 2013
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL...
K131191 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 87d
Cleared Jul 22, 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 76d
Cleared Jul 22, 2013
MICRO AMBULATORY ECG RECORDER
K131572 · DPS
Dimetek Digital Medical Technologies,...
Cardiovascular · 52d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418 · JSS
Advandx, Inc.
Microbiology · 257d
Cleared Jul 19, 2013
TRANSCEND
K120510 · GEI
Syneron Medical, Ltd.
General & Plastic Surgery · 514d
Cleared Jul 19, 2013
KLOCKNER DENTAL IMPLANT ABUTMENTS
K122988 · NHA
SOADCO, S.L.
Dental · 296d
Cleared Jul 19, 2013
T1040 AKA AURAWAVE
K124055 · NUH
Endurance Therapeutics
Neurology · 200d
Cleared Jul 19, 2013
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
K130068 · BYJ
Essex Industries, Inc. D/B/A Essex...
Anesthesiology · 189d
Cleared Jul 19, 2013
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
K130079 · MUD
Reflectance Medical, Inc.
Cardiovascular · 186d
Cleared Jul 19, 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE...
K130136 · GXZ
Technomed Europe
Neurology · 182d
Cleared Jul 19, 2013
ELIXBO PM545
K130658 · LNH
Xbo Medical Systems Co., Ltd.
Radiology · 129d
Cleared Jul 19, 2013
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
K130731 · HRS
Stabiliz Orthopaedics, LLC
Orthopedic · 123d
Cleared Jul 19, 2013
NAVIGATION PIN
K131130 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 87d
Cleared Jul 19, 2013
IHEALTH CLOUD
K131203 · DXN
Andon Health Co, Ltd.
Cardiovascular · 81d
Cleared Jul 19, 2013
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
K131332 · DYB
Cardiosolutions, Inc.
Cardiovascular · 71d
Cleared Jul 19, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · DKZ
Ucp Biosciences, Inc.
Toxicology · 30d
Cleared Jul 18, 2013
NAOMI-CT
K123332 · OAS
Lk Consulting Group
Radiology · 265d
Cleared Jul 18, 2013
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
K130088 · MUH
Genoray Co., Ltd.
Radiology · 185d
Cleared Jul 18, 2013
ICT
K130224 · JAK
Imris, Inc.
Radiology · 170d