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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62257–62280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2006
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT,...
K061065 · KHE
Teco Diagnostics
Hematology · 88d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · LZO
Smith & Nephew, Inc.
General & Plastic Surgery · 88d
Cleared Jul 14, 2006
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jul 14, 2006
GC XLC-100 CAPSULE
K061535 · EMA
GC America, Inc.
Dental · 42d
Cleared Jul 14, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
K061641 · IYO
Shimadzu Medical Systems
Radiology · 32d
Cleared Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
K061710 · DQY
St Jude Medical
Cardiovascular · 25d
Cleared Jul 13, 2006
CORAMATE/SPIROTOME SYSTEM
K060384 · KNW
Medinvents
Gastroenterology & Urology · 149d
Cleared Jul 13, 2006
PRODIGY BLOOD GLUCOSE TEST SYSTEM
K060467 · NBW
Diagnostic Devices, Inc.
Chemistry · 140d
Cleared Jul 13, 2006
BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100
K061514 · ING
Bruno Independent Living Aids, Inc.
Physical Medicine · 42d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · JIT
Dade Behring, Inc.
Chemistry · 22d
Cleared Jul 12, 2006
FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
K051688 · NUC
Trimensa Pharmaceuticals
Obstetrics & Gynecology · 384d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246 · LZO
Smith & Nephew, Inc.
Orthopedic · 233d
Cleared Jul 12, 2006
IPLAN RT DOSE
K053584 · MUJ
Brainlab AG
Radiology · 201d
Cleared Jul 12, 2006
NFIX FUSION SYSTEM
K053623 · MNH
N-Spine, Inc.
Orthopedic · 196d
Cleared Jul 12, 2006
ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
K060191 · ILY
Accelerated Care Plus Corp.
Physical Medicine · 168d
Cleared Jul 12, 2006
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
K060232 · GEI
Trokamed GmbH
General & Plastic Surgery · 163d
Cleared Jul 12, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · NDN
Arthrocare Corp.
Orthopedic · 145d
Cleared Jul 12, 2006
QL LOCKING SYRINGE
K060643 · MAV
Atrion Medical Products, Inc.
Cardiovascular · 124d
Cleared Jul 12, 2006
FEATHERLITE AQUA TOCODYNAMOMETER
K061044 · HFM
Ventrex, Inc.
Obstetrics & Gynecology · 89d
Cleared Jul 12, 2006
NEOZOLINE VENTILATION TUBES
K061058 · ETD
Adept Medical, Ltd.
Ear, Nose, Throat · 86d
Cleared Jul 12, 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · DYB
St Jude Medical
Cardiovascular · 57d
Cleared Jul 12, 2006
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
K061365 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 57d
Cleared Jul 12, 2006
TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
K061452 · DXN
Tung FU Electric Co., Ltd.
Cardiovascular · 48d
Cleared Jul 12, 2006
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
K061593 · OCL
AtriCure, Inc.
Cardiovascular · 34d