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
51337–51360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · GEI
Arthrocare Corp.
General & Plastic Surgery · 220d
Cleared Jan 15, 2010
SMART-WELL EZTEST INCUBATOR
K091950 · FRC
Sgm Biotech, Inc.
General Hospital · 198d
Cleared Jan 15, 2010
THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K092743 · JEY
Stryker Craniomaxillofacial
Dental · 129d
Cleared Jan 15, 2010
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
K092878 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 119d
Cleared Jan 15, 2010
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
K093223 · GWQ
Compumedics Limited
Neurology · 94d
Cleared Jan 15, 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K093358 · HCG
MicroVention, Inc.
Neurology · 79d
Cleared Jan 15, 2010
ADAGIO RETRACTING ECG LEAD WIRES
K093657 · DSA
Acist Medical Systems, Inc.
Cardiovascular · 51d
Cleared Jan 15, 2010
HALO 360 & SIZING BALLOON, MODEL 3441C
K093855 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 30d
Cleared Jan 15, 2010
SORIN C5 SYSTEM MODEL 58-00-00
K093882 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 28d
Cleared Jan 15, 2010
PICA CATHETER
K093970 · LIT
Penumbra, Inc.
Cardiovascular · 23d
Cleared Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL...
K082275 · LCP
Infopia Co, Ltd.
Chemistry · 521d
Cleared Jan 14, 2010
W&H HANDPIECE ANESTO, MODEL: RA-5
K083811 · EGM
W&H Dentalwerk Buermoos GmbH
Dental · 388d
Cleared Jan 14, 2010
HYDROCOAT MESH
K090271 · FTL
Promethean Surgical Devices, Inc.
General & Plastic Surgery · 344d
Cleared Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
K091867 · CDZ
Siemens Healthcare Diagnostics
Chemistry · 205d
Cleared Jan 14, 2010
ASCENSION METAL GREAT TOE SYSTEM
K092047 · KWD
Ascension Orthopedics, Inc.
Orthopedic · 192d
Cleared Jan 14, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · NLH
Sterilmed, Inc.
Cardiovascular · 182d
Cleared Jan 14, 2010
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627 · IMG
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 141d
Cleared Jan 14, 2010
DISPOSABLE HYPODERMIC NEEDLE
K092831 · FMI
Feel Tech
General Hospital · 121d
Cleared Jan 14, 2010
TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD...
K092893 · DXN
Tytan Medical Corp.
Cardiovascular · 115d
Cleared Jan 14, 2010
SAF (SELF ADJUSTING FILE)
K092933 · EFB
Redent-Nova , Ltd.
Dental · 113d
Cleared Jan 14, 2010
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · MAL
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Jan 14, 2010
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
K093308 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 84d
Cleared Jan 14, 2010
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
K093518 · DZE
Ace Surgical Supply Co., Inc.
Dental · 62d
Cleared Jan 14, 2010
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
K093519 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 62d