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
77809–77832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2001
LUXAGLAZE
K013179 · EBD
Dmg USA, Inc.
Dental · 18d
Cleared Oct 12, 2001
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · IXA
Ferrania USA, Inc.
Radiology · 15d
Cleared Oct 12, 2001
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE...
K013286 · LYY
Tillotson Healthcare Corp.
General Hospital · 10d
Cleared Oct 11, 2001
CRYOCARE SURGICAL SYSTEM
K003811 · GEH
Endocare, Inc.
General & Plastic Surgery · 304d
Cleared Oct 11, 2001
EPOCA CUSTOM OFFSET SHOULDER SYSTEM
K010869 · KWT
Argomedical AG
Orthopedic · 202d
Cleared Oct 11, 2001
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
K011080 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 185d
Cleared Oct 11, 2001
LEVEEN ELECTRODE
K012315 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 80d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · KKX
Standard Textile Co., Inc.
General Hospital · 50d
Cleared Oct 11, 2001
THECURVE, ITEM 507
K012935 · MFD
Select Medical Systems, Inc.
Obstetrics & Gynecology · 41d
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · GEX
Candela Corp.
General & Plastic Surgery · 31d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · KDI
Gambro Renal Products
Gastroenterology & Urology · 191d
Cleared Oct 10, 2001
MODIFICATION TO A620 EEG
K012011 · HCC
Stoelting Co.
Neurology · 104d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · JFY
Wiener Laboratories Saic
Chemistry · 100d
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · JWH
Howmedica Osteonics
Orthopedic · 90d
Cleared Oct 10, 2001
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
K012263 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
SNOWPOST, SNOWLIGHT
K012354 · ELR
Danville Materials, Inc.
Dental · 77d
Cleared Oct 10, 2001
HELIX HYDRO-JET
K012464 · FQH
Andreas Pein Medizintechnik GmbH
General Hospital · 70d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · JDC
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 10, 2001
RHODIA DENTAL PUTTY IMPRESSION MATERIAL
K013129 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013140 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · JHI
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Cook, Inc.
Anesthesiology · 280d