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

Filters: Cleared only ×
175,820 results
48913–48936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2010
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
K102514 · NKB
Nuvasive, Inc.
Orthopedic · 91d
Cleared CT Dec 01, 2010
VITALA CONTINENCE CONTROL DEVICE
K102536 · EZQ
Convatec, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 01, 2010
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
K102543 · FFT
Given Imaging , Ltd.
Gastroenterology & Urology · 89d
Cleared Dec 01, 2010
LLX240AB01
K102587 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 83d
Cleared Dec 01, 2010
TOMOPHASE OCTIS
K102599 · NQQ
Tomophase Corporation
General & Plastic Surgery · 82d
Cleared Dec 01, 2010
SL3
K102639 · GEX
Discus Dental, LLC
General & Plastic Surgery · 78d
Cleared Dec 01, 2010
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
K103214 · DRG
Lifeline Systems, Inc.
Cardiovascular · 30d
Cleared Dec 01, 2010
HEPARIN ASSAY CONTROLS
K103313 · GGN
Medtronic, Inc.
Hematology · 21d
Cleared Nov 30, 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
K102638 · JIT
Diazyme Laboratories
Chemistry · 77d
Cleared Nov 30, 2010
STAXX(R) XD SYSTEM
K102682 · MQP
Spine Wave, Inc.
Orthopedic · 74d
Cleared Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
K093626 · DAP
Siemens Healthcare Diagnostics
Hematology · 370d
Cleared Nov 29, 2010
EQUINOX CO2 LASER SYSTEM
K100487 · ONG
Eclipsemed Global, Inc.
General & Plastic Surgery · 283d
Cleared Nov 29, 2010
VENUS FREEZE SYSTEM
K100586 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 272d
Cleared Nov 29, 2010
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
K100920 · CAW
Sequal Technologies Co., Ltd.
Anesthesiology · 241d
Cleared Nov 29, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR
K101590 · MQB
VATECH Co., Ltd.
Radiology · 175d
Cleared Nov 29, 2010
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC...
K101794 · OTJ
Advanced Surgical Concepts
General & Plastic Surgery · 154d
Cleared Nov 29, 2010
ICESENCE 3
K102360 · GEH
IceCure Medical , Ltd.
General & Plastic Surgery · 102d
Cleared Nov 29, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW...
K102790 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 63d
Cleared Nov 26, 2010
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
K100199 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 308d
Cleared Nov 26, 2010
MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
K101784 · DYB
Great Batch Medical
Cardiovascular · 154d
Cleared Nov 26, 2010
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
K102548 · KNT
Footprint Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 24, 2010
ARROW ANATOMICAL SHOULDER SYSTEM
K093599 · KWS
Fournitures Hospitalieres Industrie
Orthopedic · 369d
Cleared Nov 24, 2010
MAX-IF1000
K100246 · LIH
Bio Protech, Inc.
Neurology · 301d
Cleared Nov 24, 2010
PLASMALUXLS
K100628 · ONE
Daavlin Distributing Co.
General & Plastic Surgery · 264d