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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
72385–72408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2003
HEMOBAG, MODEL HBBSD2000
K031150 · DTN
Global Blood Resources, LLC
Cardiovascular · 74d
Cleared Jun 23, 2003
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
K031346 · OBJ
Jomed, Inc.
Cardiovascular · 55d
Cleared Jun 23, 2003
3TP SOFTWARE OPTION
K031350 · LNH
3tp, LLC
Radiology · 55d
Cleared Jun 23, 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · FLL
Vivant Medical, Inc.
General Hospital · 35d
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · MQP
Depuyacromed
Orthopedic · 27d
Cleared Jun 20, 2003
NLITE SYSTEM, MODEL#: A00-1025/A00-1033
K024189 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 183d
Cleared Jun 20, 2003
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · MCW
Fox Hollow Technologies
Cardiovascular · 179d
Cleared Jun 20, 2003
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
K024259 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 179d
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