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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71785–71808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2003
CTXA HIP EXTENDED REFERENCE DATA
K030330 · KGI
Mindways Software, Inc.
Radiology · 140d
Cleared Jun 20, 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared Jun 20, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE...
K030963 · HCG
Cordis Neurovascular, Inc.
Neurology · 85d
Cleared Jun 20, 2003
SENSE BODY COIL
K031095 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 74d
Cleared Jun 20, 2003
SCANX 10
K031198 · MQB
Air Techniques, Inc.
Radiology · 65d
Cleared Jun 20, 2003
CONSULTIVA REPORT STATION, MODEL RS-1
K031248 · LLZ
Miramedica, Inc.
Radiology · 63d
Cleared Jun 20, 2003
INTEGRADWEB BY DYNAMIC IMAGING, INC.
K031311 · LLZ
Dynamic Imaging, Inc.
Radiology · 57d
Cleared Jun 20, 2003
HF MODULE WITH TRANSDUCERS
K031391 · IYO
Ophthalmic Technologies, Inc.
Radiology · 49d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · HCH
Cardinalhealth
Neurology · 42d
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · LFX
Beckman Coulter, Inc.
Microbiology · 29d
Cleared Jun 20, 2003
DATEX-OHMEDA HMEF 750
K031653 · CAH
Datex-Ohmeda
General Hospital · 23d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared Jun 20, 2003
C.CAM
K031825 · KPS
Danish Diagnostic Development A/S
Radiology · 7d
Cleared Jun 20, 2003
AUTOBONE
K031871 · JAK
Ge Medical Systems Europe
Radiology · 3d
Cleared Jun 20, 2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
K031872 · KPS
Adac Laboratories
Radiology · 3d
Cleared Jun 19, 2003
CARE ETS
K023036 · IPF
Care Rehab and Orthopaedic
Physical Medicine · 280d
Cleared Jun 19, 2003
C-1805M
K023815 · EIA
Anodia Systems
Dental · 216d
Cleared Jun 19, 2003
C-1890
K023896 · EIA
Anodia Systems
Dental · 209d
Cleared Jun 19, 2003
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL...
K024093 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 190d
Cleared Jun 19, 2003
CP MEDICAL BONE WAX
K024372 · MTJ
Cp Medical
General & Plastic Surgery · 170d
Cleared Jun 19, 2003
GENICON LAPAROSCOPES
K030174 · GCJ
Genicon, LC
General & Plastic Surgery · 153d
Cleared Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · HNO
Oasis Medical, Inc.
Ophthalmic · 133d
Cleared Jun 19, 2003
SKINSTATION
K030897 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC
Inion , Ltd.
Orthopedic · 87d