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
71497–71520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2003
CORIX 70 PLUS-USV
K031802 · EHD
Coramex, S.A.
Radiology · 40d
Cleared Jul 21, 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846 · GEI
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
CARDIOVATIONS RETRACTOR
K031847 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE...
K031912 · LON
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 21, 2003
AMPLAID A756 SCREENING ADMITTANCE METER
K031978 · ETY
Amplaid
Ear, Nose, Throat · 25d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 21, 2003
BRODA MODEL 587 MANUAL WHEELCHAIR
K032133 · IOR
Broda Ent., Inc.
Physical Medicine · 10d
Cleared Jul 21, 2003
SITE-RITE IV ULTRASOUND SYSTEM
K032135 · IYO
Dymax Corp
Radiology · 10d
Cleared Jul 18, 2003
DIADEXUS PLAC TEST
K030477 · NOE
Diadexus, Inc.
Chemistry · 155d
Cleared Jul 18, 2003
PROVIDENCE MOLDING HELMET
K030669 · MVA
Northeast Orthotics and Prothetics, Inc.
Neurology · 137d
Cleared Jul 18, 2003
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K031057 · JOH
Portex, Inc.
Anesthesiology · 106d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jul 18, 2003
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS
K031477 · LPL
Ocular Sciences, Inc.
Ophthalmic · 70d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · KNG
Koven Technology, Inc.
Radiology · 65d
Cleared Jul 18, 2003
BRAIN COIL, MODEL 9900GE-64
K031536 · MOS
Clinical MR Solutions, LLC
Radiology · 63d
Cleared Jul 18, 2003
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
K031631 · IYE
3D Line USA, Inc.
Radiology · 52d
Cleared Jul 18, 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
K031821 · FGE
Cook, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 18, 2003
MODIFICATION TO WBR, MODEL HR
K031874 · KPS
U.C.G. Technologies , Ltd.
Radiology · 31d
Cleared Jul 18, 2003
SCANTEC PAD
K031894 · MUI
Sonotech, Inc.
Radiology · 29d
Cleared Jul 18, 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · DYB
St Jude Medical
Cardiovascular · 28d
Cleared Jul 18, 2003
PHILIPS VIEWFORUM 2003
K032096 · LLZ
Philips Medical Systems
Radiology · 10d
Cleared Jul 18, 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
K032111 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared Jul 17, 2003
ELECTROMEDICARIN 900
K020478 · IPF
Electromedicarin, S.A.
Physical Medicine · 519d
Cleared Jul 17, 2003
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K021841 · BTL
Pneupac , Ltd.
Anesthesiology · 407d