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
40081–40104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2013
REXTAR X
K132041 · EHD
Meta Biomed, Inc.
Radiology · 29d
Cleared Jul 31, 2013
ARTHREX SPEEDCINCH
K132043 · GAT
Arthrex, Inc.
General & Plastic Surgery · 29d
Cleared Jul 30, 2013
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
K122458 · DRG
Cello Partnership D/B/A Verizon Wireless
Cardiovascular · 351d
Cleared Jul 30, 2013
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
K122532 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 344d
Cleared Jul 30, 2013
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
K124000 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 216d
Cleared Jul 30, 2013
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM,...
K130302 · MNI
Spinevision S.A.
Orthopedic · 173d
Cleared Jul 30, 2013
BROADMASTER HEALTHCARE SYSTEM
K130621 · NBW
Broadmaster Biotech Corporation
Chemistry · 144d
Cleared Jul 30, 2013
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
K130949 · DZE
Biomet 3i
Dental · 116d
Cleared Jul 30, 2013
CURA COMPENSATOR
K131150 · IXI
Cura Medical Technologies, LLC
Radiology · 98d
Cleared Jul 30, 2013
COALITION SPACER
K131449 · OVE
Globus Medical, Inc.
Orthopedic · 71d
Cleared Jul 30, 2013
NEUROBLATE(TM) SYSTEM
K131955 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 33d
Cleared Jul 30, 2013
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT,...
K132008 · DTD
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM...
K122091 · MPB
Cook, Inc.
Gastroenterology & Urology · 378d
Cleared Jul 29, 2013
OPHTACATH KIT
K123831 · OKS
France Chirurgae Instrumentation
Ophthalmic · 229d
Cleared Jul 29, 2013
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
K130059 · PBQ
Ibi Israel Biomedical Innovations , Ltd.
Obstetrics & Gynecology · 200d
Cleared Jul 29, 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · QEW
Medrad, Inc.
Cardiovascular · 165d
Cleared Jul 29, 2013
PTFE SUPER SHEATH INTRODUCER
K130855 · DYB
Martech Medical Products
Cardiovascular · 123d
Cleared Jul 29, 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · MBI
Arthocare Corporation
Orthopedic · 94d
Cleared Jul 29, 2013
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · DWJ
Covidien
Cardiovascular · 77d
Cleared Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 48d
Cleared Jul 26, 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
K121445 · OYE
Beckman Coulter, Inc.
Hematology · 437d
Cleared Jul 26, 2013
VDRIVE W/V-SONO
K122659 · DQX
Stereotaxis, Inc.
Cardiovascular · 329d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721 · JWH
Medacta International
Orthopedic · 234d
Cleared Jul 26, 2013
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
K123768 · NZA
STERIS Corporation
General Hospital · 231d