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
79897–79920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · NDW
Trace America, Inc.
Chemistry · 58d
Cleared Jan 17, 2001
HYALURONIDASE REAGENT, MODEL CAT#2212
K003751 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 43d
Cleared Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING...
K003895 · KGO
Ansell Perry
General Hospital · 30d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · DQO
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jan 16, 2001
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jan 16, 2001
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT...
K003771 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 41d
Cleared Jan 16, 2001
PATTERN RESIN
K003817 · EBG
GC America, Inc.
Dental · 36d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · KRX
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 12, 2001
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
K001259 · DZE
Basic Dental Implant Systems, Inc.
Dental · 268d
Cleared Jan 12, 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775 · DRT
Zoe Medical, Inc.
Cardiovascular · 214d
Cleared Jan 12, 2001
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · CGJ
Genua 1944, Inc.
Chemistry · 156d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · KHE
Enterix, Inc.
Hematology · 155d
Cleared Jan 12, 2001
GEON DIGITAL CLINICAL THERMOMETER
K003223 · FLL
Geon Corp.
General Hospital · 88d
Cleared Jan 12, 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · DZE
Lifecore Biomedical, Inc.
Dental · 88d
Cleared Jan 12, 2001
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
K003231 · GZJ
Home Medical Services
Neurology · 87d
Cleared Jan 12, 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · JDC
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 12, 2001
MS-ONE, MODEL MS-1
K003258 · GZJ
Home Wellness West
Neurology · 86d
Cleared Jan 12, 2001
E.N.S.I. RETRACTABLE SAFETY SYRINGE
K003348 · MEG
Ensi-Med International Pty. , Ltd.
General Hospital · 78d
Cleared Jan 12, 2001
GUARDED NEEDLE 2000
K003406 · FMI
International Medical Device...
General Hospital · 72d
Cleared Jan 12, 2001
MPS ACACIA PAIN KIT
K003476 · MEB
Mps Acacia
General Hospital · 64d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Hardy Diagnostics
Microbiology · 43d