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
95257–95280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1997
HEDROCEL ACETABULAR RESTRICTOR
K962468 · JDI
Implex Corp.
Orthopedic · 223d
Cleared Feb 03, 1997
TOTALCARE
K962942 · FNL
Hill-Rom, Inc.
General Hospital · 189d
Cleared Feb 03, 1997
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
K963248 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Feb 03, 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · JDI
Osteonics Corp.
Orthopedic · 143d
Cleared Feb 03, 1997
SYS STIM 226
K964028 · IPF
Mettler Electronics Corp.
Physical Medicine · 119d
Cleared Feb 03, 1997
RTA RETINAL THICKNESS ANALYZER
K964137 · HLI
Talia Technology , Ltd.
Ophthalmic · 111d
Cleared Feb 03, 1997
SMARTOAE
K964426 · EWO
Intelligent Hearing Systems
Ear, Nose, Throat · 90d
Cleared Feb 03, 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · MGQ
Procyte Corp.
General & Plastic Surgery · 89d
Cleared Feb 03, 1997
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
K964472 · KYI
Biologically Oriented Prostheses
Orthopedic · 88d
Cleared Feb 03, 1997
MULTITAK SS SUTURE SYSTEM
K964532 · MBI
Bonutti Research
Orthopedic · 83d
Cleared Feb 03, 1997
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS...
K964662 · DXC
Rmds, Inc.
Cardiovascular · 74d
Cleared Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743 · HQE
Storz Instrument Co.
Ophthalmic · 69d
Cleared Feb 03, 1997
ENTRACARE THERMOMTER MODEL 1000
K964851 · FLL
Entracare Corp.
General Hospital · 62d
Cleared Feb 03, 1997
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · LBB
Mekanika, Inc.
Neurology · 55d
Cleared Jan 31, 1997
CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
K962587 · MKO
Conceptus, Inc.
Obstetrics & Gynecology · 214d
Cleared Jan 31, 1997
IMAGYN FALLOPOSCOPY SYSTEM
K963580 · MKO
Imagyn Medical, Inc.
Obstetrics & Gynecology · 147d
Cleared Jan 31, 1997
STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
K963765 · GEI
Stryker Endoscopy
General & Plastic Surgery · 134d
Cleared Jan 31, 1997
SHUNT TAP WITH ICP MONITORING ACCESS PORT
K964371 · JXG
Integra Neurocare, LLC
Neurology · 91d
Cleared Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386 · JXG
Radionics, Inc.
Neurology · 88d
Cleared Jan 31, 1997
CHASE VESSEL OCCLUDER
K964390 · MJN
Chase Medical, Inc.
Cardiovascular · 88d
Cleared Jan 31, 1997
ULTRA-ETCH STAT
K965060 · EBF
Ultradent Products, Inc.
Dental · 44d
Cleared Jan 30, 1997
STERILEMAX
K953938 · FLE
Barnstead/Thermolyne Corp.
General Hospital · 528d
Cleared Jan 30, 1997
P1OP2B OR P1O92T
K954674 · FYA
Kay Borch A/S
General Hospital · 478d
Cleared Jan 30, 1997
PATIENT EXAMINATION GLOVE
K961521 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 283d