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
36889–36912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · KCT
Intuitive Surgical
General Hospital · 221d
Cleared Aug 01, 2014
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO...
K140100 · NBW
Nipro Diagnostics, Inc.
Chemistry · 198d
Cleared Aug 01, 2014
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K140551 · MQB
Perkinelmer, Inc.
Radiology · 150d
Cleared Aug 01, 2014
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
K140953 · KOD
Convatec, Ltd.
Gastroenterology & Urology · 109d
Cleared Aug 01, 2014
ENSIZOR ENDOSCOPIC SCISSORS
K141058 · OCZ
Slater Endoscopy, LLC
Gastroenterology & Urology · 99d
Cleared Aug 01, 2014
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 99d
Cleared Aug 01, 2014
REMOTEYE VIEWER
K141061 · LLZ
Neologica S.R.L.
Radiology · 99d
Cleared Aug 01, 2014
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
K141302 · LLZ
Vital Images, Inc.
Radiology · 74d
Cleared Aug 01, 2014
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K141353 · BTT
Teleflexmedical, Inc.
Anesthesiology · 70d
Cleared Aug 01, 2014
SMC ACUPUNCTURE NEEDLE
K141473 · MQX
Smc Intl., Inc.
General Hospital · 59d
Cleared Aug 01, 2014
FUTURABOND M+
K141610 · KLE
Voco GmbH
Dental · 46d
Cleared Aug 01, 2014
JUSHA-C61 LCD MONITOR
K141679 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-C33C LCD MONITOR
K141684 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-M33C LCD MONITOR
K141690 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
K141841 · MQV
Integra Lifescience Corportation
Orthopedic · 24d
Cleared Aug 01, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5...
K141859 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Jul 31, 2014
SILVER DENTAL ARREST
K102973 · PHR
Cooley Consulting, Inc.
Dental · 1394d
Cleared Jul 31, 2014
SYVEK RADIAL BAND
K132293 · DXC
Marine Polymer Technologies
Cardiovascular · 373d
Cleared Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
K133725 · MOF
MicroVention, Inc.
Neurology · 237d
Cleared Jul 31, 2014
S9 GREENHILLS
K140279 · BZD
Resmed, Ltd.
Anesthesiology · 178d
Cleared Jul 31, 2014
SENSILIGHT MINI
K140527 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 149d
Cleared Jul 31, 2014
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
K140603 · GEI
Saphena Medical, Inc.
General & Plastic Surgery · 143d
Cleared Jul 31, 2014
ARGEN PMMA
K140894 · EBG
The Argen Corporation
Dental · 114d
Cleared Jul 31, 2014
ENDOSIZE
K141475 · LLZ
Therenva Sas
Radiology · 57d