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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38617–38640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2014
INJECTION NEEDLE
K132065 · FBK
Endochoice, Inc.
Gastroenterology & Urology · 198d
Cleared Jan 17, 2014
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
K132410 · JAK
Ge Medical Systems, LLC
Radiology · 168d
Cleared Jan 17, 2014
IOB DISPOSABLE SPECULUM
K132668 · HIB
Iob Medical, Inc.
Obstetrics & Gynecology · 143d
Cleared Jan 17, 2014
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY...
K132682 · MCW
Atheromed, Inc.
Cardiovascular · 142d
Cleared Jan 17, 2014
SUPRAPUBIC CATHETER AND INTRODUCER SET
K132890 · KOB
Mediplus , Ltd.
Gastroenterology & Urology · 123d
Cleared Jan 17, 2014
GALAXY PLUS
K132921 · MQB
Medien International Co, Ltd.
Radiology · 122d
Cleared Jan 17, 2014
APOLLO SYSTEM
K132931 · GWG
Penumbra, Inc.
Neurology · 121d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 17, 2014
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
K133228 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 88d
Cleared Jan 17, 2014
XARIO 100
K133277 · IYN
Toshibamedical Systems Corporation
Radiology · 85d
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 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