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
59545–59568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2007
BIO-CONSOLE, MODEL 560
K070286 · DWA
Medtronic
Cardiovascular · 113d
Cleared May 22, 2007
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45,...
K070396 · DYB
Acumen Medical, Inc.
Cardiovascular · 99d
Cleared May 22, 2007
EUROIMMUN ANA IFA: HEP-20-10
K070763 · DHN
Euroimmun Us, LLC
Immunology · 63d
Cleared May 22, 2007
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
K070827 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 57d
Cleared May 22, 2007
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
K070831 · LLZ
Barcoview Mis Edinburgh
Radiology · 57d
Cleared May 22, 2007
FUJI IP CASSETTE TYPE PC
K070920 · IYE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 50d
Cleared May 22, 2007
PANOSOL II TRU-BLU, MODEL UBL-417
K070934 · FTC
National Biological Corp.
General & Plastic Surgery · 49d
Cleared May 22, 2007
SEA2 SELF ETCH ADHESIVE
K070956 · KLE
3M Espe Dental Products
Dental · 47d
Cleared May 22, 2007
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 43d
Cleared May 22, 2007
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
K071040 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 40d
Cleared May 22, 2007
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
K071054 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 36d
Cleared May 22, 2007
.DECIMAL RANGE COMPENSATOR
K071078 · IXI
.Decimal, Inc.
Radiology · 35d
Cleared May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
K071099 · LNH
Imris, Inc.
Radiology · 33d
Cleared May 22, 2007
SYNGO IMAGING (VERSION V30)
K071114 · LLZ
Siemens AG Medical Solutions
Radiology · 32d
Cleared May 22, 2007
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
K071311 · MOS
Neocoil
Radiology · 13d
Cleared May 22, 2007
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K071314 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared May 21, 2007
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
K063494 · HBL
Pro-Med Instruments GmbH
Neurology · 182d
Cleared May 21, 2007
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
K070295 · MNI
Trinity Orthopedics, LLC
Orthopedic · 110d
Cleared May 21, 2007
MEDILAS D FAMILY LASERS
K070536 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 84d
Cleared May 21, 2007
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
K070759 · FCF
Vidacare Corporation
Gastroenterology & Urology · 62d
Cleared May 21, 2007
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
K071006 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 42d
Cleared May 21, 2007
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K071076 · LON
Dade Behring, Inc.
Microbiology · 35d
Cleared May 21, 2007
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
K071188 · NHT
Idaho Technology, Inc.
Microbiology · 21d
Cleared May 18, 2007
FEMTEN CERVICAL TENACULUM
K062563 · HDC
Fem Suite, LLC
Obstetrics & Gynecology · 260d