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
75745–75768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 15, 2002
SIMIDUR S2
K020192 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR KF PLUS
K020194 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR S1S
K020195 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
K020217 · JJX
Bayer Diagnostics Corp.
Chemistry · 52d
Cleared Mar 15, 2002
CLASSIC TENS
K020437 · GZJ
Care Rehab, Inc.
Neurology · 35d
Cleared Mar 15, 2002
GAZELLE WHEELCHAIR
K020536 · IOR
Alum Creek Wheelchair Co., Inc.
Physical Medicine · 24d
Cleared Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
K020632 · QYX
Mennen Medical , Ltd.
Cardiovascular · 16d
Cleared Mar 15, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · DZE
BioHorizons Implant Systems, Inc.
Dental · 15d
Cleared Mar 14, 2002
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K012350 · FWP
Porex Surgical, Inc.
General & Plastic Surgery · 232d