FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75385–75408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · LOD
Exactech, Inc.
Orthopedic · 20d
Cleared Jun 12, 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · GZJ
Apex Medical Corp.
Neurology · 14d
Cleared Jun 11, 2002
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
K012512 · NCX
Radiant Medical
Neurology · 309d
Cleared Jun 11, 2002
PLEXOLONG SETS
K013041 · CAZ
Pajunk GmbH
Anesthesiology · 274d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131 · HWC
Linvatec Corp.
Orthopedic · 265d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared Jun 11, 2002
OXYARM CO2
K014211 · CCK
Southmedic, Inc.
Anesthesiology · 172d