Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37897–37920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 2014
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
K140562 · KNY
Leomed, LLC
Gastroenterology & Urology · 103d
Cleared Jun 16, 2014
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL
K140570 · EBI
Zest Anchors, LLC
Dental · 102d
Cleared Jun 16, 2014
NXSTAGE EXPRESS FLUID WARMER
K140623 · FLA
Nxstage Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jun 16, 2014
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
K140708 · FRC
STERIS Corporation
General Hospital · 87d
Cleared Jun 16, 2014
PLANMECA ROMEXIS
K140713 · LLZ
Planmeca Oy
Radiology · 87d
Cleared Jun 16, 2014
BONASTENT BILIARY
K140760 · FGE
Endochoice, Inc.
Gastroenterology & Urology · 82d
Cleared Jun 16, 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · LYA
ArthroCare Corporation
Ear, Nose, Throat · 60d
Cleared Jun 14, 2014
REPROCESSED HARMONIC SHEAR
K132566 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 303d
Cleared Jun 13, 2014
DENTAL IMPLANT SYSTEM
K122807 · DZE
Hager& Meisinger GmbH
Dental · 652d
Cleared Jun 13, 2014
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE,...
K131080 · ILY
Reimers and Janssen GmbH
Physical Medicine · 445d