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
42889–42912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2012
ERCHONIA ZERONA
K121695 · OLI
Erchonia Corporation
General & Plastic Surgery · 77d
Cleared Aug 23, 2012
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
K121824 · ELW
Lascod Spa
Dental · 63d
Cleared Aug 23, 2012
THERMAL LIGATING SHEARS
K122086 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 38d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 22, 2012
EON CALCIUM REGENT
K120626 · CJY
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 174d
Cleared Aug 22, 2012
PROLYTE ELECTROLYTE ANALYZER
K121140 · JGS
Diamond Diagnostics, Inc.
Chemistry · 128d
Cleared Aug 22, 2012
SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
K121181 · KNW
Alliance Partners, LLC
Gastroenterology & Urology · 126d
Cleared Aug 22, 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Aug 22, 2012
OSTEOMED CRANIAL DISTRACTION SYSTEM
K121304 · PBJ
Osteomed
Neurology · 113d
Cleared Aug 22, 2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
K121536 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared Aug 22, 2012
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE...
K121550 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 89d
Cleared Aug 22, 2012
SYSTEM, X-RAY, STATIONARY
K121854 · KPR
Beijing Sinopharm Hundric Mediline...
Radiology · 58d
Cleared Aug 22, 2012
GENESYS PRESSFT SUTURE ANCHOR
K121890 · MAI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 55d
Cleared Aug 22, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · JHW
Elitechgroup
Chemistry · 37d
Cleared Aug 21, 2012
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC...
K111627 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 438d
Cleared Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
K111914 · OEO
Olympus America Inc. / Scientific...
Pathology · 412d
Cleared Aug 21, 2012
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE...
K112916 · NBW
Tyson Bioresearch, Inc.
Chemistry · 323d
Cleared Aug 21, 2012
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI...
K113062 · FBP
Endoservice Optical Instruments GmbH
Gastroenterology & Urology · 312d
Cleared Aug 21, 2012
HY-CHLO(TM)WOUND SCRUB
K113312 · FQH
Patrin Pharma
General Hospital · 286d
Cleared Aug 21, 2012
MTA-FILLAPEX
K113568 · KIF
Paxmed International
Dental · 263d
Cleared Aug 21, 2012
CLEVER CHOICE
K120921 · CGA
Simple Diagnostics, Inc.
Chemistry · 147d
Cleared Aug 21, 2012
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
K121063 · IYN
Ge Medical System Israel , Ltd.
Radiology · 137d
Cleared Aug 21, 2012
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
K121485 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 95d