FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
30073–30096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2017
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K162924 · LZA
Hartalega Sdb. Bhd.
General Hospital · 98d
Cleared Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 24, 2017
AOS Small Bone Nailing System
K163014 · HSB
Advanced Orthopaedic Solutions, Inc....
Orthopedic · 88d
Cleared Jan 24, 2017
EzRay Air W
K163705 · EHD
VATECH Co., Ltd.
Radiology · 26d
Cleared Jan 24, 2017
nvc
K170074 · ODP
Nvision Biomedical Technologies, LLC
Orthopedic · 15d
Cleared Jan 23, 2017
D.O.R.C. Disposable Cryo Probe
K160591 · HRN
Dutch Ophthalmic Research Center...
Ophthalmic · 328d
Cleared Jan 23, 2017
Facilis™ Spinal System
K161231 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 266d
Cleared Jan 23, 2017
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
K161275 · MQH
Research Instruments Limited
Obstetrics & Gynecology · 262d
Cleared Jan 23, 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy...
K161823 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 206d
Cleared Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606 · JLW
Roche Diagnostics
Chemistry · 126d
Cleared Jan 23, 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · NDN
Globus Medical, Inc.
Orthopedic · 125d
Cleared Jan 23, 2017
OrthAlign Plus System
K162962 · OLO
Orthalign, Inc.
Orthopedic · 91d
Cleared Jan 23, 2017
Lifestyles Zero Lubricated Latex Male Condom
K163107 · HIS
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 77d
Cleared Jan 19, 2017
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
K160589 · PQX
Certa Dose, Inc.
General Hospital · 324d
Cleared Jan 19, 2017
Medline Waste Station
K160660 · DQO
Medline Industries, Inc.
Cardiovascular · 317d
Cleared Jan 19, 2017
Cranial PSI
K161090 · GXN
Ossdsign AB
Neurology · 276d
Cleared Jan 19, 2017
da Vinci Xi Surgical System
K161178 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 268d
Cleared Jan 19, 2017
meso-relle (AAL34, AAL36, AM30G)
K161255 · FMI
Biotekne Srl
General Hospital · 261d
Cleared Jan 19, 2017
Anatomic Total Knee System
K161414 · JWH
Amplitude
Orthopedic · 241d
Cleared Jan 19, 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation...
K161418 · OMP
Cardinalhealth
General & Plastic Surgery · 241d
Cleared CT Jan 19, 2017
Juno VPAP ST-A
K161492 · MNS
Resmed, Ltd.
Anesthesiology · 232d
Cleared Jan 19, 2017
GMI Frontier Dental Implant System
K161593 · DZE
Ilerimplant S.L
Dental · 224d
Cleared Jan 19, 2017
Polysmith Sleep System, Model NTI7593
K161650 · OLV
Neurotronics, Inc.
Neurology · 218d
Cleared Jan 19, 2017
Fever Scout™ Continuous Monitoring thermometer
K162137 · FLL
VivaLNK, Inc.
General Hospital · 171d