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

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176,076 results
75985–76008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2002
ORACAM
K020957 · EIA
Video Dental Concepts, Inc.
Dental · 80d
Cleared Jun 13, 2002
RPI REPLACEMENT HEATING ELEMENTS
K020966 · FMT
Replacement Parts Industries, Inc.
General Hospital · 80d
Cleared Jun 13, 2002
SYNGO MR 2002B
K020991 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Jun 13, 2002
MAMMOPATH
K021113 · MWP
Fischer Imaging Corp.
Radiology · 69d
Cleared Jun 13, 2002
PRECISET DAT PLUS
K021393 · DKB
Quantimetrix Corp.
Toxicology · 42d
Cleared Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · MOS
Medical Advances, Inc.
Radiology · 38d
Cleared Jun 13, 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · DQY
Cordis Corp.
Cardiovascular · 29d
Cleared Jun 13, 2002
GP GENERAL PURPOSE DRAINAGE CATHETER
K021632 · GBO
Uresil, L.P.
General & Plastic Surgery · 27d
Cleared Jun 13, 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · KPS
Nuclear Diagnostics
Radiology · 24d
Cleared Jun 13, 2002
RS2MI MUSCLE STIMULATOR FAMILY
K021763 · IPF
Rs Medical
Physical Medicine · 15d
Cleared Jun 12, 2002
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
K012701 · JOZ
Accumetrics, Inc.
Hematology · 302d
Cleared Jun 12, 2002
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
K012969 · LTZ
Medtech Products , Ltd.
Obstetrics & Gynecology · 281d
Cleared Jun 12, 2002
AFB (ABSORBABLE FOAM BUTTRESS)
K014183 · FTL
J&J Corporate Biomaterials Center
General & Plastic Surgery · 174d
Cleared Jun 12, 2002
ACUSTIM
K014273 · BWK
S.H.P. Intl. Pty., Ltd.
Neurology · 167d
Cleared Jun 12, 2002
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
K020827 · NUC
Personal Products Co., Div. of Mcneil...
Obstetrics & Gynecology · 90d
Cleared Jun 12, 2002
BD INTROSYTE PRECISION INTRODUCER
K020834 · DYB
Becton Dickinson Infusion Therapy...
Cardiovascular · 90d
Cleared Jun 12, 2002
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
K020835 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 12, 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 12, 2002
ULTRA-LITE 5 TURBO LIGHT CURE UNIT
K020874 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE TURBO LIGHT CURE UNIT
K020877 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE LIGHT CURE UNIT
K020884 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
ESOP CO-CR FEMORAL HEADS
K021109 · LPH
Fournitures Hospitalieres
Orthopedic · 68d
Cleared Jun 12, 2002
DERMMATRIX SURGICAL MESH
K021160 · FTM
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 62d
Cleared Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · MOS
Mri Devices Corp.
Radiology · 29d