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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68545–68568 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2004
SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
K032454 · DZE
Bio-Lok Intl., Inc.
Dental · 206d
Cleared Mar 04, 2004
HIOX80 AEROSOL ADAPTER
K032516 · CAF
Sensor Medics Corp.
Anesthesiology · 203d
Cleared Mar 04, 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · BZD
Respironics, Inc.
Anesthesiology · 175d
Cleared Mar 04, 2004
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060 · JIT
Diamond Diagnostics, Inc.
Chemistry · 157d
Cleared Mar 04, 2004
IV ADMINISTRATION AND CONNECT SETS
K033301 · FPA
Codan US Corp.
General Hospital · 142d
Cleared Mar 04, 2004
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
K033842 · GCJ
Vernon-Carus Limited
General & Plastic Surgery · 85d
Cleared Mar 04, 2004
SHIRAZ POSTERIOR SYSTEM
K033947 · MNI
Spine Next America
Orthopedic · 76d
Cleared Mar 04, 2004
SHIRAZ-ANTERIOR SYSTEM
K033965 · KWQ
Spine Next America
Orthopedic · 73d
Cleared Mar 04, 2004
CONTINUM V
K040180 · EJH
Aalba Dent, Inc.
Dental · 37d
Cleared Mar 04, 2004
MESACUP-2 TEST CENP-B
K040200 · LJM
Rhigene, Inc.
Immunology · 35d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 20d
Cleared Mar 04, 2004
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
K040507 · BTT
Taga Medical Technologies, Inc.
Anesthesiology · 6d
Cleared Mar 03, 2004
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
K031114 · MRB
Raven Biological Laboratories, Inc.
General Hospital · 330d
Cleared Mar 03, 2004
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
K031903 · DTZ
Guidant Corporation
Cardiovascular · 257d
Cleared Mar 03, 2004
HIGH SPEED EMG MODULE
K031930 · GWF
Medical Measurement Systems B.V.
Neurology · 254d
Cleared Mar 03, 2004
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
K031935 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 254d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · DRT
Shenzhen Mindray Bio-Medical...
Cardiovascular · 181d
Cleared Mar 03, 2004
ATRION MEDICAL QL INFLATION DEVICE
K032840 · KOE
Atrion Medical Products, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 03, 2004
POWDERED LATEX EXAMINATION GLOVES
K033531 · LYY
Apl International Incorporated Limited
General Hospital · 114d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 70d
Cleared Mar 03, 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · KPO
B.Braun Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d