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
37585–37608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2014
VITAL SIGNS MONITOR
K132037 · MWI
Mindray North America
Cardiovascular · 319d
Cleared May 16, 2014
NUVASIVE NVM5 SYSTEM
K132694 · PDQ
Nu Vasive, Incorporated
Neurology · 260d
Cleared May 16, 2014
BIOPSY PIPETTES
K133257 · MQH
Research Instruments , Ltd.
Obstetrics & Gynecology · 205d
Cleared May 16, 2014
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
K133519 · JJE
Carolina Liquid Chemistries Corp.
Chemistry · 182d
Cleared May 16, 2014
TEMPUS PRO EXTENDED FEATURES
K133988 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 141d
Cleared May 16, 2014
RESCAN
K140054 · BZD
Resmed, Ltd.
Anesthesiology · 127d
Cleared May 16, 2014
AXERA RX ACCESS SYSTEM
K140287 · DYB
Arstasis, Inc.
Cardiovascular · 100d
Cleared May 16, 2014
LUMENA FH HAIR REMOVAL SYSTEM
K140631 · ONF
Shaser, Inc.
General & Plastic Surgery · 65d
Cleared May 16, 2014
VSCAN WITH DUAL PROBE
K140693 · IYN
Ge Medical Sysyems Ultrasound &...
Radiology · 58d
Cleared May 16, 2014
KLASSIC KNEE TIBIAL STEM EXTENSION
K140942 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 32d
Cleared May 16, 2014
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
K141041 · OTD
Aptus Endosystems
Cardiovascular · 23d
Cleared May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · JJE
Jas Diagnostics, Inc.
Chemistry · 408d
Cleared May 15, 2014
FETAL MONITORS
K131941 · HGM
Guangdong Biolight Meditech Co., Ltd.
Obstetrics & Gynecology · 322d
Cleared May 15, 2014
EXTRICARE
K132225 · OMP
Devon Medical, Inc.
General & Plastic Surgery · 302d
Cleared May 15, 2014
RXG DISTRACTION SYSTEM
K133304 · JEY
KLS-Martin L.P.
Dental · 199d
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · HWC
Smith & Nephew, Inc.
Orthopedic · 167d
Cleared May 15, 2014
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
K133664 · KGI
Ge Medical Systems Ultrasound &...
Radiology · 167d
Cleared May 15, 2014
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR...
K133752 · ELC
Sonendo, Inc.
Dental · 157d
Cleared May 15, 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 155d
Cleared May 15, 2014
FIREFLY
K134001 · NGX
Firstkind Limited
Physical Medicine · 139d
Cleared May 15, 2014
INFUSET FLOW CONTROL EXTENSION SET
K140133 · FPA
Emed Technologies Corporation
General Hospital · 118d
Cleared May 15, 2014
RAY STATION
K140187 · MUJ
Raysearch Laboratories AB
Radiology · 111d
Cleared May 15, 2014
XGEO GR40CW
K140235 · MQB
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared May 15, 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · KRA
Boston Scientific
Cardiovascular · 94d