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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
45001–45024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2012
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH...
K113422 · FMI
Terumo (Philippines) Corporation
General Hospital · 105d
Cleared Mar 05, 2012
PLIF CAGE
K113478 · MAX
Eisertech, LLC
Orthopedic · 103d
Cleared Mar 05, 2012
TI-MAX X TURBINE
K113655 · EFB
Nakanishi, Inc.
Dental · 84d
Cleared Mar 05, 2012
LIME-LITE II
K113711 · EJK
Pulpdent Corporation
Dental · 77d
Cleared Mar 05, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
K113750 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 75d
Cleared Mar 02, 2012
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
K103081 · JXI
Biom'Up Sas
Neurology · 500d
Cleared Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · LYR
Gold Standard Diagnostics
Microbiology · 351d
Cleared Mar 02, 2012
CS 1600 INTRAORAL CAMERA
K111423 · NBL
Carestream Health, Inc.
Dental · 284d
Cleared Mar 02, 2012
GLIDER PTCA BALLOON CATHETER
K111544 · LOX
Trireme Medical, Inc.
Cardiovascular · 273d
Cleared Mar 02, 2012
VENUS FREEZE (MP)2 SYSTEM
K111670 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 261d
Cleared Mar 02, 2012
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964 · JJY
Aalto Scientific, Ltd.
Chemistry · 235d
Cleared Mar 02, 2012
E-CARE INFRARED EAR THERMOMETER
K113095 · FLL
E-Care Technology Corporation
General Hospital · 135d
Cleared Mar 02, 2012
LASER HELMET
K113097 · OAP
Theradome, Inc.
General & Plastic Surgery · 135d
Cleared Mar 02, 2012
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
K113264 · DXN
Ld Technology, LLC
Cardiovascular · 119d
Cleared Mar 02, 2012
KNOTILUS ANCHOR SYSTEM
K113297 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 115d
Cleared CT Mar 02, 2012
SOLITAIRE FR REVASCULARIZATION DEVICE
K113455 · NRY
Micro Therapeutics Dba Ev3 Neurovascular
Neurology · 102d
Cleared Mar 02, 2012
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · DXO
St Jude Medical
Cardiovascular · 88d
Cleared Mar 02, 2012
C-THV SYSTEM
K113594 · IZI
Paieon, Inc.
Radiology · 88d
Cleared Mar 02, 2012
SPEE-DEE PATCH
K113617 · EBF
Pulpdent Corporation
Dental · 86d
Cleared Mar 02, 2012
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340
K113784 · LLZ
Eizo Nanao Corporation
Radiology · 71d
Cleared Mar 02, 2012
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
K113797 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 70d
Cleared Mar 02, 2012
DELTAMAXX 18 MICROCOIL SYSTEM
K120274 · HCG
Codman and Shurtleff, Inc.
Neurology · 32d
Cleared Mar 01, 2012
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
K111426 · ITX
Houston Medical Robotics
Radiology · 283d
Cleared Mar 01, 2012
FD TENS 2070
K111654 · GZJ
Fuji Dynamics , Ltd.
Neurology · 262d