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
35833–35856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2014
XN CAL
K141962 · KRX
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK
K141964 · JPK
Streck
Hematology · 140d
Cleared Dec 05, 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052 · KTT
Orthofix Srl
Orthopedic · 130d
Cleared Dec 05, 2014
QUALITY REPORTS
K142142 · IYE
Sun Nuclear Corporation
Radiology · 122d
Cleared Dec 05, 2014
Discovery MR750 3.0T
K142361 · LNH
Ge Medical Systems, LLC
Radiology · 102d
Cleared Dec 05, 2014
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
K142365 · OCC
Focus Diagnostics
Microbiology · 102d
Cleared Dec 05, 2014
Passeo-35 PTA Catheter
K142379 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Dec 05, 2014
Neo Total Knee System
K142388 · JWH
New Era Orthopedics, LLC
Orthopedic · 100d
Cleared Dec 05, 2014
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared Dec 05, 2014
WaterProof PROFILER
K142431 · IYE
Sun Nuclear Corporation
Radiology · 98d
Cleared Dec 05, 2014
ONEFIT HIP PLANNER
K142671 · LLZ
Onefit Medical
Radiology · 77d
Cleared Dec 05, 2014
Siemens 3.0T PROCURE Array Coil
K142676 · MOS
Resonance Innovations, LLC
Radiology · 77d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
K143194 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 05, 2014
Viscoelastic Injector
K143205 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Dec 05, 2014
Schoelly Laparoscope
K143221 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 25d
Cleared Dec 04, 2014
B TRAVELSAVVY SHARPS CONTAINER
K140285 · MMK
Bellegrove Medical Supply, Inc.
General Hospital · 303d
Cleared Dec 04, 2014
CUROS RED PORT PROTECTOR
K140657 · QBP
Ivera Medical, Inc.
General Hospital · 265d
Cleared Dec 04, 2014
VESOFLOW PLUS DVT COMPRESSION DEVICE
K141064 · JOW
Caremed Supply, Inc.
Cardiovascular · 224d
Cleared Dec 04, 2014
MARK3
K141092 · ELW
Cavex Holland BV
Dental · 220d
Cleared Dec 04, 2014
PULSE OXIMETER
K141105 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 219d
Cleared Dec 04, 2014
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
K141613 · LYZ
Zibo Goldenline Plastic Product Co.,...
General Hospital · 171d
Cleared Dec 04, 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 169d