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
77977–78000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2001
BLY-501 ADAPTOR
K012540 · DPS
Micromedical Industries, Ltd.
Cardiovascular · 50d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Sep 25, 2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
K010891 · LSK
Digene Corp.
Microbiology · 183d
Cleared Sep 25, 2001
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
K012004 · GEI
Senorx, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2001
XBO1-824-18/19/20 BIOPSY FORCEPS
K012074 · OCZ
The Olympus Optical Co.
Gastroenterology & Urology · 85d
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106 · JAK
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 25, 2001
HP-ONE
K012411 · LYR
Gi Supply
Microbiology · 57d
Cleared Sep 25, 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865 · GAW
Sutura, Inc.
General & Plastic Surgery · 29d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · DYB
St Jude Medical
Cardiovascular · 25d
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · MOS
Mri Devices Corp.
Radiology · 8d
Cleared Sep 24, 2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
K010892 · LSK
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
K010893 · LSL
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
PROMAX-XP, TENS AND MICROCURRENT DEVICE
K011017 · GZJ
Rehabilicare, Inc.
Neurology · 173d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 88d
Cleared Sep 24, 2001
VACUETTE EDTA K2 GEL TUBES
K012043 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 87d
Cleared Sep 24, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
K012149 · LYY
Allegiance Healthcare Corp.
General Hospital · 76d
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 73d
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 69d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · LNH
GE Medical Systems
Radiology · 20d
Cleared Sep 24, 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Sep 21, 2001
INTRA OPERATIVE RADIATION THERAPY
K004023 · IYE
Arplay Medical S.A.
Radiology · 268d
Cleared Sep 21, 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232 · LZA
P.T. Healthcare Glovindo
General Hospital · 240d
Cleared Sep 21, 2001
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
K010844 · NAK
Astoria-Pacific, Inc.
Chemistry · 184d