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
77377–77400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 01, 2001
CODMAN BACTISEAL CATHETERS
K003322 · HCA
Codman & Shurtleff, Inc.
Neurology · 342d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049 · LMA
Vidar Systems Corp.
Radiology · 178d
Cleared Oct 01, 2001
XLTEK LED GOGGLES, MODEL LED-01
K011794 · GWE
Excel Tech. , Ltd.
Neurology · 115d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2001
CYTOFLEX
K012144 · LYC
Unicare Biomedical, Inc.
Dental · 83d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105,...
K012176 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 81d
Cleared Oct 01, 2001
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
K012227 · IYE
Oncology Data Systems, Inc.
Radiology · 77d
Cleared Oct 01, 2001
DOSERIGHT
K012238 · JAK
Philips Medical Systems North America...
Radiology · 76d
Cleared Oct 01, 2001
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
K012283 · FMI
Safegard Medical Products, Inc.
General Hospital · 73d