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
76777–76800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2002
DOC BAND
K014012 · OAN
Cranial Technologies, Inc.
Neurology · 54d
Cleared Jan 28, 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 53d
Cleared Jan 28, 2002
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING
K014055 · LYY
Seal Polymer Industries Bhd.
General Hospital · 49d
Cleared Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · MRR
Beckman Coulter, Inc.
Chemistry · 46d
Cleared Jan 28, 2002
VOXAR'S CALCIUM SCORING PRODUCT
K020140 · LLZ
Voxar Limited
Radiology · 12d
Cleared Jan 25, 2002
CRYOCARE SURGICAL SYSTEM
K011074 · GEH
Endocare, Inc.
General & Plastic Surgery · 291d
Cleared Jan 25, 2002
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K012937 · HAW
Medtronic Surgical Navigation...
Neurology · 147d
Cleared Jan 25, 2002
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K013091 · HBB
Von Zeppelin GmbH
Neurology · 130d
Cleared Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · OCL
Medtronic Vascular
Cardiovascular · 102d
Cleared Jan 25, 2002
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K013507 · GZJ
Cosmo Health, Inc.
Neurology · 95d
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 25, 2002
PERICSCOPE, MODEL # PERISC1
K013576 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · DSY
Atrium Medical Corp.
Cardiovascular · 88d
Cleared Jan 25, 2002
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · BSP
B.Braun Medical, Inc.
Anesthesiology · 81d
Cleared Jan 25, 2002
FINGER JOINT PROSTHESIS
K013629 · KYJ
Avanta Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jan 25, 2002
RIBBOND - TRIAXIAL
K013881 · EBI
Ribbond, Inc.
Dental · 63d
Cleared Jan 25, 2002
T2 FEMORAL NAIL SYSTEM
K014220 · HSB
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
K014223 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · MNH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jan 25, 2002
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400,...
K014294 · DQA
Medical Data Electronics
Anesthesiology · 28d
Cleared Jan 25, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · DZE
BioHorizons Implant Systems, Inc.
Dental · 10d
Cleared Jan 24, 2002
ANCURE SHEATH MODEL # 40315, 40320, 40325
K003889 · DYB
Guidant Cardiac and Vascular Surgery
Cardiovascular · 402d