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
77881–77904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 03, 2001
THE SALICEPT ORAL PATCH
K012126 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 89d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · DSI
Medical Data Electronics
Cardiovascular · 71d
Cleared Oct 03, 2001
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
K012345 · IPL
Bromac Assistive Technology
Physical Medicine · 71d
Cleared Oct 03, 2001
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K012446 · BSZ
Charles A. Smith
Anesthesiology · 63d
Cleared Oct 03, 2001
ATAC PAK CPK REAGENT KIT
K012474 · CGS
Elan Holdings, Inc.
Chemistry · 62d
Cleared Oct 03, 2001
EASYTRAVEL
K012592 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 54d
Cleared Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
K012948 · MSD
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 29d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · GEI
Aesculap, Inc.
General & Plastic Surgery · 27d
Cleared Oct 03, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS...
K012992 · DQA
Masimo Corp.
Anesthesiology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2
K013009 · EBF
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Oct 03, 2001
MODIFICATION TO FLOUROLAB PLUS
K013025 · HAW
Z-Kat, Inc.
Neurology · 23d
Cleared Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 667d
Cleared Oct 02, 2001
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE),...
K012383 · FRN
Alaris Medical Systems, Inc.
General Hospital · 67d
Cleared Oct 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
K012435 · NGY
Bausch & Lomb, Inc.
Ophthalmic · 63d
Cleared Oct 02, 2001
SUNLITELED MODEL #2810
K012946 · EBZ
Kinetic Instruments, Inc.
Dental · 28d
Cleared Oct 02, 2001
SMARTFLOW
K012947 · DQK
Florence Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 02, 2001
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952 · DSY
Boston Scientific/Medi-Tech
Cardiovascular · 28d
Cleared Oct 02, 2001
COOLTOUCH VARIZOOM
K012982 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 27d
Cleared Oct 02, 2001
NEXUS 2 MODIFIED
K013008 · EMA
Sybron Dental Specialties, Inc.
Dental · 26d
Cleared Oct 02, 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE...
K013104 · FPA
Sterling Medivations, Inc.
General Hospital · 15d
Cleared Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · MQB
Cares Built, Inc.
Radiology · 349d