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
95449–95472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
K965157 · DIF
Boehringer Mannheim Corp.
Toxicology · 25d
Cleared Jan 16, 1997
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099 · MNH
Buckman Co., Inc.
Orthopedic · 737d
Cleared Jan 16, 1997
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
K960508 · HIR
The Prometheus Group
Gastroenterology & Urology · 346d
Cleared Jan 16, 1997
OMNIPULSE/OMNIPULSE-MAX
K962632 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 195d
Cleared Jan 16, 1997
CTS MIDCAB/SVH BIPOLAR SCISSORS
K963930 · GEI
Cardiothoracic Systems, Inc.
General & Plastic Surgery · 107d
Cleared Jan 16, 1997
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP,...
K964258 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 83d
Cleared Jan 16, 1997
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
K964350 · JDI
Intermedics Orthopedics
Orthopedic · 77d
Cleared Jan 16, 1997
KINAMED PROFIX SYSTEM
K964362 · HRS
Kinamed, Inc.
Orthopedic · 76d
Cleared Jan 16, 1997
SOFSILK
K964581 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 62d
Cleared Jan 16, 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC...
K964601 · LFL
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared Jan 16, 1997
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
K964848 · MFD
Marlow Surgical Technologies, Inc.
Obstetrics & Gynecology · 44d
Cleared Jan 15, 1997
N RHEUMATOLOGY STANDARD SL
K964527 · JIX
Behring Diagnostics, Inc.
Immunology · 64d
Cleared Jan 15, 1997
BHI W/VANCOMYCIN AGAR
K964560 · JSO
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 15, 1997
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
K964991 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 33d
Cleared Jan 14, 1997
MAYO HIP PROSTHESIS
K943230 · LPH
Mayo Clinic
Orthopedic · 923d