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
37297–37320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2014
KONIX STERILE GEL
K130581 · MUI
Turkuaz Saglik Hizmetleri Medikal...
Radiology · 470d
Cleared Jun 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130733 · LYZ
Benteng Plastic Co., Ltd.
General Hospital · 457d
Cleared Jun 18, 2014
ABB VIE J
K133096 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 261d
Cleared Jun 18, 2014
QUALIS
K133295 · MQK
Menicon Co., Ltd. New Business Division
Obstetrics & Gynecology · 236d
Cleared Jun 18, 2014
QARDIOARM
K140067 · DXN
Qardio, Inc.
Cardiovascular · 159d
Cleared Jun 18, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
K140583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 104d
Cleared Jun 18, 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX
Tornier, Inc.
Orthopedic · 57d
Cleared Jun 18, 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
K141313 · KRD
Reverse Medical Corporation
Cardiovascular · 29d
Cleared Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS...
K141363 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 17, 2014
ULTRA RENEW PLUS
K132833 · OLP
Accord Media
General & Plastic Surgery · 280d
Cleared Jun 17, 2014
EASYPOINT NEEDLE
K133635 · FMI
Retractable Technologies, Inc.
General Hospital · 203d
Cleared Jun 17, 2014
S9 WANDA VPAP ST
K140159 · BZD
Resmed, Ltd.
Anesthesiology · 146d
Cleared Jun 17, 2014
BI-FLEX URETERAL ACCESS SHEATH
K140441 · KNY
Promepla Sam
Gastroenterology & Urology · 116d
Cleared Jun 17, 2014
KEELER KAPTURE SOFTWARE
K140450 · HKI
Keeler Limited
Ophthalmic · 113d
Cleared Jun 16, 2014
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
K132289 · JAA
Gemss Medical Systems Co., Ltd.
Radiology · 328d
Cleared Jun 16, 2014
PILLING ESOPHAGEAL BOUGIES
K133439 · FAT
Teleflexmedical, Inc.
Gastroenterology & Urology · 216d
Cleared Jun 16, 2014
OTC EMS STIMULATOR
K133965 · NGX
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 174d
Cleared Jun 16, 2014
ENDOSHIELD BURN PROTECTION SYSTEM
K140006 · GEI
Encision, Inc.
General & Plastic Surgery · 165d
Cleared Jun 16, 2014
U2 FEMORAL COMPONENT, CR, CEMENTED
K140073 · JWH
United Orthopedic Corp.
Orthopedic · 154d
Cleared Jun 16, 2014
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL...
K140134 · BZT
Starboard Medical, LLC
Anesthesiology · 150d
Cleared Jun 16, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
K140215 · DIS
Co-Innovation Biotech Co., Ltd.
Toxicology · 139d
Cleared Jun 16, 2014
EMBRYOGEN
K140317 · MQL
Origio A/S
Obstetrics & Gynecology · 126d
Cleared Jun 16, 2014
ARIETTA 60/ARIETTAS60/ARIETTAV60
K140443 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 115d
Cleared Jun 16, 2014
RECOVERY PUMP 737R
K140519 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 108d