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
94921–94944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1997
MEDILOG VISION
K961636 · OLZ
Oxford Instruments, Plc.
Neurology · 263d
Cleared Jan 17, 1997
MEDILOG MPA-S
K961638 · OLV
Oxford Instruments Medical Systems
Neurology · 263d
Cleared Jan 17, 1997
MEDILOG MR95
K961642 · GWQ
Oxford Instruments, Plc.
Neurology · 263d
Cleared Jan 17, 1997
HSW GMBH ARTHROSCOPE
K962075 · HRX
Henke Sass Wolf of America, Inc.
Orthopedic · 234d
Cleared Jan 17, 1997
DIGITAL IMAGE ANALYSIS SYSTEM
K962153 · LLZ
University of Washington
Radiology · 227d
Cleared Jan 17, 1997
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 226d
Cleared Jan 17, 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 210d
Cleared Jan 17, 1997
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
K962648 · CBQ
Ohmeda Medical
Anesthesiology · 193d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · CGA
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Jan 17, 1997
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · JZO
Diagnostic Products Corp.
Immunology · 123d
Cleared Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
K963872 · HET
Gynecare Innovation Center
Obstetrics & Gynecology · 113d
Cleared Jan 17, 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304 · MNH
Osteonics Corp.
Orthopedic · 80d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · LNH
General Electric Co.
Radiology · 80d
Cleared Jan 17, 1997
IPU RX-2
K964327 · LLZ
Medirex, Inc.
Radiology · 79d
Cleared Jan 17, 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330 · DZE
BioHorizons Implant Systems, Inc.
Dental · 78d
Cleared Jan 17, 1997
PULPDENT SNOOP
K964430 · LFC
Pulpdent Corp.
Dental · 73d
Cleared Jan 17, 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548 · ERL
Linvatec Corp.
Ear, Nose, Throat · 65d
Cleared Jan 17, 1997
XRT-7.0
K964583 · JAK
Elscint, Inc.
Radiology · 63d
Cleared Jan 17, 1997
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
K964586 · FCW
Iba/Griffith
Gastroenterology & Urology · 63d
Cleared Jan 17, 1997
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)
K964772 · EJT
Ivoclar North America, Inc.
Dental · 51d
Cleared Jan 17, 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 49d
Cleared Jan 17, 1997
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K964856 · GKZ
Caltag Laboratories, Inc.
Hematology · 44d
Cleared Jan 17, 1997
DIGISCOPE RX-2 (9 OPTION)
K965013 · OXO
Medirex, Inc.
Radiology · 32d
Cleared Jan 17, 1997
AST/SGOT
K965126 · CIT
Derma Media Lab., Inc.
Chemistry · 25d