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
44065–44088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2012
INFINITI(R) VISION SYSTEM
K120912 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 81d
Cleared Jun 15, 2012
FORA COMFORTSCAN EAR THERMOMETER
K121118 · FLL
Foracare, Inc.
General Hospital · 64d
Cleared Jun 15, 2012
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
K121130 · NKB
Biomet Spine
Orthopedic · 63d
Cleared Jun 15, 2012
MEDYSSY LT CAGE SYSTEM
K121246 · MAX
Medyssey Co, Ltd.
Orthopedic · 51d
Cleared Jun 15, 2012
1.5T 16CH FLEX SPEEDER LARGE
K121362 · MOS
Neocoil, LLC
Radiology · 39d
Cleared Jun 15, 2012
ST AIA-PACK HOMOCYSTEINE
K121533 · LPS
Tosoh Bioscience, Inc.
Chemistry · 22d
Cleared Jun 14, 2012
SYNTHES SCOUT TACK FIXATION
K111048 · OMR
Synthes Spine
Orthopedic · 426d
Cleared Jun 14, 2012
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136 · NKB
Depuy Spine, Inc.
Orthopedic · 419d
Cleared Jun 14, 2012
KODAMA INTRAVASCULAR ULRASOUND CATHETER
K113008 · OBJ
Silicon Vally Medical Instruments, Inc.
Cardiovascular · 251d
Cleared Jun 14, 2012
ULTRASONIC SURGERY MACHINE
K113152 · DZI
Dmetec.Co., Ltd.
Dental · 233d
Cleared Jun 14, 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · NKB
Globus Medical, Inc.
Orthopedic · 210d
Cleared Jun 14, 2012
FUSION FLAT PANEL
K113449 · MQB
Icrco, Inc.
Radiology · 206d
Cleared Jun 14, 2012
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K120648 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 104d
Cleared Jun 14, 2012
CHISON DIAGNOSTIC ULTRASOUND SYSTEM
K120801 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 90d
Cleared Jun 14, 2012
OBIX PERINATAL DATA SYSTEM 7.0
K121208 · HGM
Clinical Computer Systems, Inc.
Obstetrics & Gynecology · 55d
Cleared Jun 14, 2012
VECTOR
K121385 · LIT
R4 Vascular, Inc.
Cardiovascular · 37d
Cleared Jun 14, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K121442 · LIT
Cordis Corporation
Cardiovascular · 30d
Cleared Jun 14, 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · OCL
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jun 14, 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jun 14, 2012
SUREFIRE HI-FLOW MICROCATHETER
K121677 · DQO
Surefire Medical, Inc.
Cardiovascular · 7d
Cleared Jun 13, 2012
SONIXGPS NEEDLE SENSOR
K111818 · IYO
Ultrasonix Medical Corporation
Radiology · 351d
Cleared Jun 13, 2012
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
K112897 · OQG
Renovis Surgical Technologies, LLC
Orthopedic · 254d
Cleared Jun 13, 2012
HONOUR SPACER SYSTEM
K120345 · ODP
Nexxt Spine, LLC
Orthopedic · 131d
Cleared Jun 13, 2012
PARIETEX COMPOSITE VENTRAL PATCH
K120506 · FTL
Sofradim Production
General & Plastic Surgery · 113d