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
59281–59304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · NKB
Medtronic Sofamor Danek
Orthopedic · 199d
Cleared Jun 28, 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · MQP
Theken Spine, LLC
Orthopedic · 98d
Cleared Jun 28, 2007
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
K071396 · KPT
Capintec, Inc.
Radiology · 38d
Cleared Jun 28, 2007
SMS GLUCOSE CONTROL, MODEL 2120059
K071433 · JJY
Specialty Medical Supplies
Chemistry · 36d
Cleared Jun 28, 2007
ECHELON SPECTROSCOPY PACKAGE
K071506 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Jun 28, 2007
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
K071611 · MOS
Neocoil
Radiology · 15d
Cleared Jun 27, 2007
EZPACS, VERSION 3.0
K062878 · LLZ
Advanced Imaging Solutions, LLC
Radiology · 274d
Cleared Jun 27, 2007
TITANIUM SCALLOPED ABUTMENT
K063768 · NHA
Vident
Dental · 189d
Cleared Jun 27, 2007
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH...
K070619 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 114d
Cleared Jun 27, 2007
HABIB HEXABLATE
K071103 · GEI
Emcision , Ltd.
General & Plastic Surgery · 69d
Cleared Jun 27, 2007
REGIUS UNITEA
K071436 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 35d
Cleared Jun 27, 2007
GE LUNAR BODY COMPOSITION SOFTWARE
K071570 · KGI
Ge Medical Systems Lunar
Radiology · 19d
Cleared Jun 26, 2007
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS
K070572 · MSD
Ash Access Technology, Inc.
Gastroenterology & Urology · 118d
Cleared Jun 26, 2007
MASSAGE MATTRESS VM9100RM
K070672 · JFB
Metek GmbH
Physical Medicine · 106d
Cleared Jun 26, 2007
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS
K070791 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 96d
Cleared Jun 26, 2007
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
K070849 · NPJ
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 26, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268 · LON
Dade Behring, Inc.
Microbiology · 50d
Cleared Jun 26, 2007
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS...
K071319 · GGN
Bio-Rad, Diagnostics Grp.
Hematology · 47d
Cleared Jun 26, 2007
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K071513 · JAK
Siemens Medical Solutions
Radiology · 22d
Cleared Jun 26, 2007
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700...
K071523 · DXN
Genexel-Sein, Inc.
Cardiovascular · 22d
Cleared Jun 26, 2007
ASA01 HEAVY DUTY SUCTION PUMP
K071607 · BTA
Zhongshan A&J Medical Equipment Co.,...
General & Plastic Surgery · 14d
Cleared Jun 25, 2007
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
K063376 · CHL
Medica Corp.
Chemistry · 229d
Cleared Jun 25, 2007
SMALL STATURE SPACERS
K063393 · MQP
Biomet Spine
Orthopedic · 228d
Cleared Jun 25, 2007
BONALIVE GRANULES AND BONALIVE PLATES
K070055 · LYC
Vivoxid , Ltd.
Dental · 172d