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
94945–94968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 14, 1997
PHOENIX ETE TISSUE EXTENSION SYSTEM
K962144 · MKY
Phoenix Biomedical Corp.
General & Plastic Surgery · 225d
Cleared Jan 14, 1997
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · BZE
Marquest Medical Products, Inc.
Anesthesiology · 218d
Cleared Jan 14, 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 218d
Cleared Jan 14, 1997
OLYMPUS LIPASE REAGENT
K963424 · CDT
Olympus America, Inc.
Chemistry · 137d
Cleared Jan 14, 1997
SEGUE INFUSION CATHETER
K964154 · KRA
Interventional Innovations Corp.
Cardiovascular · 90d
Cleared Jan 14, 1997
METAL ACETABULAR COMPONENT
K964227 · LPH
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jan 14, 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 81d
Cleared Jan 13, 1997
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K960511 · DWJ
Gibeck, Inc.
Cardiovascular · 343d