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
82225–82248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2000
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K993619 · BSP
Sims Portex, Inc.
Anesthesiology · 185d
Cleared Apr 28, 2000
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
K993756 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 175d
Cleared Apr 28, 2000
MODEL 120
K994372 · DQA
Palco Labs, Inc.
Anesthesiology · 123d
Cleared Apr 27, 2000
UMBICUT
K000227 · HFW
Pollak (Intl.), Ltd.
Obstetrics & Gynecology · 94d
Cleared Apr 27, 2000
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
K000537 · GAW
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 70d
Cleared Apr 27, 2000
NYLON NONABSORBABLE SURGICAL SUTURES, USP
K000539 · GAR
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 70d
Cleared Apr 27, 2000
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
K000540 · GAT
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 70d
Cleared Apr 27, 2000
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
K000701 · CFN
The Binding Site, Ltd.
Immunology · 57d
Cleared Apr 27, 2000
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
K000712 · CCK
Medical Research Laboratories, Inc.
Anesthesiology · 56d
Cleared Apr 27, 2000
STEROTACTIC LOCALIZATION DEVICE (SLD)
K000832 · LNH
Philips Medical Systems North...
Radiology · 44d
Cleared Apr 27, 2000
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
K000942 · FPA
Sims Deltec, Inc.
General Hospital · 35d
Cleared Apr 27, 2000
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
K001006 · IWB
Mds Nordion
Radiology · 29d
Cleared Apr 27, 2000
ASCENT KNEE REVISION FEMORAL STEM
K001010 · JWH
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · JJX
Roche Diagnostics Corp.
Immunology · 29d
Cleared Apr 27, 2000
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
K001019 · FPL
Hill-Rom Air-Shields
General Hospital · 28d
Cleared Apr 27, 2000
LIGHT BOND (QUICK CURE)
K001048 · DYH
Reliance Orthodontic Products, Inc.
Dental · 35d
Cleared Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE,...
K001138 · DTM
Medtronic Vascular
Cardiovascular · 17d
Cleared Apr 27, 2000
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
K994171 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 139d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · LAF
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Apr 26, 2000
VITAPORT 3
K000338 · OLV
Nihon Kohden America, Inc.
Neurology · 83d
Cleared Apr 26, 2000
K-ASSAY AT-III
K000361 · JBQ
Kamiya Biomedical Co.
Hematology · 82d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920 · MID
Corgenix, Inc.
Immunology · 35d
Cleared Apr 26, 2000
EMBOSPHERE MICROSPHERES
K991549 · HCG
Biosphere Medical
Neurology · 359d
Cleared Apr 26, 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · KWQ
Alphatec Mfg., Inc.
Orthopedic · 191d