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
35377–35400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659 · MKJ
Philips Medical Systems
Cardiovascular · 422d
Cleared Jan 23, 2015
WOUND DRESSING WITH MANUKA HONEY
K133729 · FRO
Manuka Health New Zealand , Ltd.
General & Plastic Surgery · 413d
Cleared Jan 23, 2015
ELECTRODE FOR URINARY INCONTINENCE
K140265 · KPI
Guangzhou Finecure Medical Equipment...
Gastroenterology & Urology · 354d
Cleared Jan 23, 2015
AMSEL OCCLUDER DEVICE
K140932 · FZP
Amsel Medical Corporation
General & Plastic Surgery · 287d
Cleared Jan 23, 2015
MAMMAPRINT FFPE
K141142 · NYI
Agendia
Pathology · 266d
Cleared Jan 23, 2015
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K141448 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 235d
Cleared Jan 23, 2015
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
K141511 · GEX
Cynosure, Inc.
General & Plastic Surgery · 228d
Cleared Jan 23, 2015
CAREFUSION GOLD TISSUE MARKER
K141722 · NEU
Care Fusion
General & Plastic Surgery · 212d
Cleared Jan 23, 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · MQV
Biocomposites, Ltd.
Orthopedic · 200d
Cleared Jan 23, 2015
STGC-LORDOTIC
K142030 · MQP
Cardinal Spine, LLC
Orthopedic · 182d
Cleared Jan 23, 2015
TransferMan 4m Micromanipulator
K142207 · MQJ
Eppendorf AG
Obstetrics & Gynecology · 165d
Cleared Jan 23, 2015
OsteoSeal Bone Hemostat
K142348 · MTJ
Hemostasis, LLC
General & Plastic Surgery · 154d
Cleared Jan 23, 2015
A7 Anesthesia System
K142552 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 135d
Cleared Jan 23, 2015
RIS500
K143000 · MQB
Ray Co., Ltd.
Radiology · 98d
Cleared Jan 23, 2015
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated...
K143159 · PDQ
Spineguard S.A.
Neurology · 81d
Cleared Jan 23, 2015
Quattro Bolt Tenodesis Screw
K143392 · MBI
Cayenne Medical, Inc.
Orthopedic · 58d
Cleared Jan 23, 2015
Acumed Small Fragment Base Set
K143394 · HRS
Acumed, LLC
Orthopedic · 58d
Cleared Jan 23, 2015
omni TRAX Active Patient Tracker
K143396 · IYO
Civco Medical Instruments CO Inc Dba...
Radiology · 58d
Cleared Jan 23, 2015
Cannulated Screw System
K143460 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 50d
Cleared Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
K143571 · JJX
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
K143639 · JJX
Siemens Healthcare Diagnostics
Immunology · 32d
Cleared Jan 23, 2015
Visi Mobile Monitoring System
K143751 · MWI
Sotera Wireless, Inc.
Cardiovascular · 23d
Cleared Jan 22, 2015
PODIATRY X-RAY SYSTEM
K133959 · KPR
Source-Ray, Inc.
Radiology · 394d
Cleared Jan 22, 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 392d