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
78457–78480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2001
IMAGE-X SYSTEM
K012355 · EHD
Tg Group, Inc.
Radiology · 15d
Cleared Aug 09, 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · IXA
Ferrania S.P.A.
Radiology · 14d
Cleared Aug 08, 2001
ANSPACH EMAX DRILL SYSTEM
K011444 · HBC
The Anspach Effort, Inc.
Neurology · 89d
Cleared Aug 08, 2001
REJUVENIQUE MODEL #RJV10
K011935 · NFO
Salton, Inc.
Neurology · 48d
Cleared Aug 08, 2001
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
K012054 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 37d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
LACTOSORB RAPIDFLAP
K003281 · JEY
Biomet, Inc.
Dental · 292d
Cleared Aug 07, 2001
INPULSE DENTAL LASER
K011423 · GEX
Incisive, LLC
General & Plastic Surgery · 90d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
PRAXSYS RELIA TSH TEST
K011527 · JLW
Praxsys Biosystems, Inc.
Chemistry · 82d
Cleared Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
K011695 · NPL
Collagen Matrix, Inc.
Dental · 68d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Ortho Tec, LLC
Orthopedic · 57d
Cleared Aug 07, 2001
PIT AND FISSURE CHEMICAL CURING SEALANT
K011822 · EBC
Rite-Dent Manufacturing Corp.
Dental · 57d
Cleared Aug 07, 2001
GC E-LIGHT
K012134 · EBZ
GC America, Inc.
Dental · 29d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
ACON Laboratories, Inc.
Chemistry · 22d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 06, 2001
ADD-ON CONDYLE
K002790 · NEI
Walter Lorenz Surgical, Inc.
Dental · 333d
Cleared Aug 06, 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · GYB
Skylark Device & Systems Co., Ltd.
Neurology · 329d
Cleared Aug 06, 2001
CROSS-CHECKS DUAL, MODEL CI 125
K010534 · JOJ
Steritec Products, Inc.
General Hospital · 164d
Cleared Aug 06, 2001
MUSCLE IMAGING SYSTEM (MIS)
K011416 · LNH
Millennium Magnetic Imaging, Inc.
Radiology · 90d
Cleared Aug 06, 2001
CHILLIT
K011666 · EAT
Heatshield, Inc.
Dental · 68d
Cleared Aug 06, 2001
FLEXICAST PRIME
K011706 · EJH
American Dent-All, Inc.
Dental · 63d