FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96625–96648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1996
HUA-XIA ACUPUNCTURE NEEDLES
K962916 · MQX
Lhasa Medical, Inc.
General Hospital · 28d
Cleared Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · JJY
Nova Biomedical Corp.
Chemistry · 22d
Cleared Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · JFL
Nova Biomedical Corp.
Chemistry · 21d
Cleared Aug 23, 1996
SUNQUEST INTERNATIONAL
K963059 · HQY
Sunquest Intl., Inc.
Ophthalmic · 21d
Cleared Aug 23, 1996
ELECSYS CALCHECK TROPONIN T
K963143 · JJX
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK TSH
K963147 · JJX
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK CK-MB
K963182 · JJX
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Aug 23, 1996
ITO ACUPUNCTURE NEEDLES
K963194 · MQX
Oms Medical Supplies, Inc.
General Hospital · 8d
Cleared Aug 22, 1996
WEEKS APPLICATOR
K951052 · IWJ
Duke University Medical Center
Radiology · 535d
Cleared Aug 22, 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL...
K960903 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 170d
Cleared Aug 22, 1996
STRYKER KNIFELIGHT
K961122 · FTD
Stryker Instruments
General & Plastic Surgery · 154d
Cleared Aug 22, 1996
SONOSCAN
K961692 · ITX
Sonotech, Inc.
Radiology · 113d
Cleared Aug 22, 1996
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K961768 · LMA
Kodak Health Imaging Systems, Inc.
Radiology · 106d
Cleared Aug 22, 1996
GENIE
K961843 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 101d
Cleared Aug 22, 1996
VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
K961861 · DZE
Implant Management of America
Dental · 100d
Cleared Aug 22, 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · MDA
Mentor Corp.
General & Plastic Surgery · 91d
Cleared Aug 22, 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL,...
K962036 · DTB
Medtronic Vascular
Cardiovascular · 90d
Cleared Aug 22, 1996
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103 · MNR
Bio-Logic Systems Corp.
Anesthesiology · 84d
Cleared Aug 22, 1996
ARTHRO-SURGIMAT
K962114 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 83d
Cleared Aug 22, 1996
GILL-THOMAS-COSMAN(GTC) DENTAL TRAY
K962155 · IYE
Radionics Software Applications, Inc.
Radiology · 79d
Cleared Aug 22, 1996
GORE SPHEREX IMPLANT
K962241 · HPZ
W.L. Gore & Associates, Inc.
Ophthalmic · 72d
Cleared Aug 22, 1996
A-DEC SELF-CONTAINED WATER SYSTEM
K962665 · EIA
A-Dec, Inc.
Dental · 44d
Cleared Aug 22, 1996
MARCELLA CARAN
K962912 · HQY
Framesmart, Inc.
Ophthalmic · 29d
Cleared Aug 22, 1996
FITO DIDO
K963075 · HQY
Framesmart, Inc.
Ophthalmic · 29d