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
76249–76272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2002
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
K020237 · JJY
Consolidated Technology
Chemistry · 55d
Cleared Mar 19, 2002
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
K020500 · SCL
Univec, Inc.
General Hospital · 33d
Cleared Mar 19, 2002
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
K020526 · FHN
Don Wilson/Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 18, 2002
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
K013201 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 174d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · GWG
Aesculap, Inc.
Neurology · 90d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154 · HWC
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · HRS
Arthrex, Inc.
Orthopedic · 89d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156 · MQV
Curasan AG
Orthopedic · 89d
Cleared Mar 18, 2002
FORTAFLEX SURGICAL MESH
K020049 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 70d
Cleared Mar 18, 2002
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED...
K020069 · HBB
Medtronic Midas Rex
Neurology · 68d
Cleared Mar 18, 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · FYA
Allegiance Healthcare Corp.
General Hospital · 24d
Cleared Mar 15, 2002
AUTODIMER ASSAY MODEL # 1431
K012755 · DAP
Xtrana, Inc.
Hematology · 211d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
XIVE DENTAL IMPLANT SYSTEM
K013867 · DZE
Friadent GmbH
Dental · 114d
Cleared Mar 15, 2002
KARMA DISCOVERY, MODEL KP40
K014127 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 88d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153 · HWC
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 15, 2002
NEW PROPHY POWDER
K014188 · KOJ
Dentsply Intl.
Dental · 84d
Cleared Mar 15, 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K020055 · JAA
Philips Medical Systems
Radiology · 66d
Cleared Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · JDW
Stryker Endoscopy
Orthopedic · 64d
Cleared Mar 15, 2002
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND...
K020126 · MUK
Surx, Inc.
Gastroenterology & Urology · 59d
Cleared Mar 15, 2002
BELLEGLASS HP MODELING GEL
K020178 · EBG
Kerr Dental Materials Center
Dental · 56d