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
77137–77160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2001
AURIS AEP
K012415 · GWJ
Synapsys, Inc.
Neurology · 141d
Cleared Dec 18, 2001
DATACAPTOR
K013019 · MWI
Capsule Technologie
Cardiovascular · 102d
Cleared Dec 18, 2001
STELLARTECH COAGULATION SYSTEM
K013139 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 90d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Dec 18, 2001
SPIRIT 300
K013251 · BYJ
Caire, Inc.
Anesthesiology · 81d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · LPS
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Radi Medical Systems AB
Cardiovascular · 19d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024 · MMI
First Medical, Inc.
Chemistry · 12d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · JFL
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Dec 18, 2001
CRESCO TI IMPLANT CONCEPT
K981052 · DZE
Cresco TI Systems AB
Dental · 1366d
Cleared Dec 17, 2001
POLESTAR N-10
K010850 · LNH
Odin Medical Technologies , Ltd.
Radiology · 271d
Cleared Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · NHG
Salimetrics, LLC
Chemistry · 230d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE...
K013302 · KGO
Allegiance Healthcare Corp.
General Hospital · 75d
Cleared Dec 17, 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013317 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 74d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
OSSEOTITE DENTAL IMPLANTS
K013570 · DZE
Implant Innovations, Inc.
Dental · 52d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · HWC
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · HWC
Triad Medical, Inc.
Orthopedic · 21d
Cleared Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
K013972 · LKF
Ackard Laboratories
Obstetrics & Gynecology · 14d