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
45169–45192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K113722 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 57d
Cleared Feb 14, 2012
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
K120132 · DXN
Philips Medical Systems
Cardiovascular · 28d
Cleared Feb 14, 2012
VICTORY GUIDEWIRE (32 MODELS)
K120137 · DQX
Brivant, Ltd.
Cardiovascular · 28d
Cleared Feb 14, 2012
VITAL SIGNS MONITOR
K120144 · DXN
Edan Instruments, Inc.
Cardiovascular · 27d
Cleared Feb 13, 2012
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP...
K111405 · GBM
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 270d
Cleared Feb 13, 2012
COFLEX-F
K112595 · KWP
Paradigm Spine, LLC
Orthopedic · 159d
Cleared Feb 13, 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406 · ELW
Dentsply International, Inc.
Dental · 87d
Cleared Feb 10, 2012
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL...
K103044 · NBW
Bestgen Biotech Corp.
Chemistry · 484d
Cleared Feb 10, 2012
EXTRICARE
K110078 · OMP
Devon Medical Products, Inc.
General & Plastic Surgery · 395d
Cleared Feb 10, 2012
PILLAR PALATAL IMPLANT SYSTEM
K110623 · LRK
Medtronic Xomed, Inc.
Dental · 344d
Cleared Feb 10, 2012
L-SER KO LAMP
K112016 · ILY
Ya-Man, Ltd.
Physical Medicine · 211d
Cleared Feb 10, 2012
KINGYIELD WRIST BLOOD PRESSURE MONITOR
K112042 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 207d
Cleared Feb 10, 2012
MESO WOUND MATRIX
K112888 · KGN
Kensey Nash Corporation
General & Plastic Surgery · 133d
Cleared Feb 10, 2012
CRE DITATATION BALLON
K112994 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 126d
Cleared Feb 10, 2012
NOTOUCH BREASTSCAN
K113259 · LHQ
Ue Lifesciences, Inc.
Radiology · 98d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 10, 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K113362 · HRX
Spine View, Inc.
Orthopedic · 87d
Cleared Feb 10, 2012
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
K113542 · BTT
Salter Labs, Arvin Facility
Anesthesiology · 71d
Cleared Feb 10, 2012
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
K113612 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 66d
Cleared Feb 10, 2012
EIGR SURGICAL ILLUMINATION SYSTEM
K113697 · FST
Invuity, Inc.
General & Plastic Surgery · 56d
Cleared Feb 10, 2012
SENSE MSK S 8CH 1.5T
K120122 · MOS
Invivo Corporation
Radiology · 24d
Cleared Feb 10, 2012
REGIUS SIGMA2
K120131 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 24d
Cleared Feb 10, 2012
AMID STAPLER
K120268 · GDW
Safestich Medical, LLC
General & Plastic Surgery · 11d
Cleared Feb 09, 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · KZH
Elcam Medical Acal
General Hospital · 259d