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
28729–28752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2017
HyPHo Laser System
K163449 · GEX
Hyper Photonics Srl
General & Plastic Surgery · 197d
Cleared Jun 23, 2017
SUITESTENSA
K163668 · LLZ
Ebit Srl
Radiology · 178d
Cleared Jun 23, 2017
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
K170094 · LYY
Vietglove Corporation
General Hospital · 163d
Cleared Jun 23, 2017
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
K170270 · FRO
Ls Scientific Inc. D.B.A. Kse Scientific
General & Plastic Surgery · 147d
Cleared Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
K170302 · HQF
Nidek Co., Ltd.
Ophthalmic · 143d
Cleared Jun 23, 2017
ReBOSSIS85
K170620 · MQV
Orthorebirth Co., Ltd.
Orthopedic · 114d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · KTI
Boston Scientific Corporation
Ear, Nose, Throat · 102d
Cleared Jun 23, 2017
LASEMD Laser System
K171009 · GEX
Lutronic Corporation
General & Plastic Surgery · 80d
Cleared Jun 23, 2017
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger...
K171146 · DQY
Arrow International, Inc. (Subsidiary...
Cardiovascular · 65d
Cleared Jun 23, 2017
Ossler Exam Scope
K171188 · DRG
Lr Med, Inc.
Cardiovascular · 60d
Cleared Jun 23, 2017
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 49d
Cleared CT Jun 22, 2017
CoVa Monitoring System 2
K160899 · MWI
Tosense, Inc.
Cardiovascular · 447d
Cleared Jun 22, 2017
Spiral Shape Dental Implant System
K162299 · DZE
Gp Implants
Dental · 310d
Cleared Jun 22, 2017
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · GIM
Caltag Medsystems, Ltd.
Immunology · 266d
Cleared Jun 22, 2017
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
K163316 · DSA
Carefusion 303, Inc.
Cardiovascular · 211d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 199d
Cleared Jun 22, 2017
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
K163412 · CCW
Girgis Scope, LLC
Anesthesiology · 199d
Cleared Jun 22, 2017
Ion PGM Dx System
K170299 · PFF
Life Technologies Corporation
Chemistry · 142d
Cleared Jun 22, 2017
VITRUVIAN INFILTRATION PUMP
K170629 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Jun 22, 2017
VariAx 2 Compression Plating System
K170727 · HRS
Stryker GmbH
Orthopedic · 105d
Cleared Jun 22, 2017
FilmArray NGDS Warrior Panel
K170883 · PRD
Biofire Defense, LLC
Microbiology · 90d
Cleared Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K170922 · NLH
Innovative Health, LLC
Cardiovascular · 85d
Cleared Jun 22, 2017
Merit Hydrophilic Guide Wire
K170933 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 85d
Cleared Jun 22, 2017
Sterile Polyisoprene Powder Free Surgical Gloves
K171047 · KGO
Better Care Plastic Technology Co., Ltd.
General Hospital · 76d