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
39217–39240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2014
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
K133375 · GCJ
Banyan Medical, LLC
General & Plastic Surgery · 74d
Cleared Jan 17, 2014
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
K133424 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared CT Jan 17, 2014
MODIFIED TREVO PROVUE RETRIEVER
K133464 · NRY
Concentric Medical, Inc.
Neurology · 66d
Cleared Jan 17, 2014
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
K133833 · IYN
Philips Ultrasound, Inc.
Radiology · 31d
Cleared Jan 17, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B...
K133869 · OZE
Center For Disease Control and...
Microbiology · 28d
Cleared Jan 17, 2014
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE...
K133875 · LLZ
Ortho Kinematics, Inc.
Radiology · 28d
Cleared Jan 16, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130732 · LYZ
Aide Plastic Co., Ltd.
General Hospital · 304d
Cleared Jan 16, 2014
CALPREST
K130945 · NXO
Eurospital S.P.A.
Immunology · 287d
Cleared Jan 16, 2014
ENDOCENTER
K131151 · ELC
Satelec - Acteon Group
Dental · 268d
Cleared Jan 16, 2014
QUICKNIT
K131799 · MVL
Microcopy, Div. of Neo-Flo, Inc.
Dental · 211d
Cleared Jan 16, 2014
Q-SWITCHED ND:YAG LASER
K131857 · GEX
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 206d
Cleared Jan 16, 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
K132363 · KTT
Citieffe S.R.L.
Orthopedic · 170d
Cleared Jan 16, 2014
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
K132528 · DXG
GE Healthcare Finland Oy
Cardiovascular · 157d
Cleared Jan 16, 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K132894 · OVE
Zimmer Spine, Inc.
Orthopedic · 122d
Cleared Jan 16, 2014
DYNESYS TOP-LOADING SPINAL SYSTEM
K133164 · NQP
Zimmer Spine, Inc.
Orthopedic · 91d
Cleared Jan 16, 2014
STARLIGHT
K133250 · OAN
Orthomerica Products, Inc.
Neurology · 86d
Cleared Jan 16, 2014
HEM-7311
K133379 · DXN
Omron Healthcare, Inc.
Cardiovascular · 73d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698 · KWP
Synthes USA Products, LLC
Orthopedic · 44d
Cleared Jan 16, 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727 · MBI
ArthroCare Corporation
Orthopedic · 41d
Cleared Jan 16, 2014
POWERGLIDE MIDLINE CATHETER
K133856 · FOZ
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110 · DKZ
Co-Innovation Biotech Co., Ltd.
Toxicology · 271d
Cleared Jan 15, 2014
BIOPHOTAS CELLUMA
K131113 · ILY
Biophotas, Inc.
Physical Medicine · 268d
Cleared Jan 15, 2014
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
K131864 · JWH
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jan 15, 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL...
K132844 · NHA
Straumann USA, LLC
Dental · 126d