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
82729–82752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2000
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
K001047 · KGO
Guthrie Medicare Products (Melaka)...
General Hospital · 28d
Cleared Apr 28, 2000
RX EVEREST
K001051 · EJT
Jeneric/Pentron, Inc.
Dental · 25d
Cleared Apr 28, 2000
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
K001094 · LYY
Jb Star Sdn Bhd
General Hospital · 24d
Cleared Apr 28, 2000
CORDIS INTRODUCER GUIDE
K001136 · DQY
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 28, 2000
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING...
K001216 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 14d
Cleared Apr 28, 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
K001270 · FJL
Gyrus Medical , Ltd.
Gastroenterology & Urology · 8d
Cleared Apr 28, 2000
GT990402 DIGITAL THERMOMETER
K001279 · FLL
Global Treasure , Ltd.
General Hospital · 7d
Cleared Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · FJS
Medionics International, Inc.
Gastroenterology & Urology · 220d
Cleared Apr 28, 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · MCW
Possis Medical, Inc.
Cardiovascular · 190d
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