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
21433–21456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2019
Upper Arm Blood Pressure Monitor
K191673 · DXN
Famidoc Technology Company Limited
Cardiovascular · 156d
Cleared Nov 27, 2019
3Shape Splint Design
K191911 · PNN
3Shape A/S
Dental · 133d
Cleared Nov 27, 2019
Orapeutic
K191987 · OLR
Forward Science
General & Plastic Surgery · 125d
Cleared Nov 27, 2019
EOSedge
K192079 · KPR
Eos Imaging
Radiology · 117d
Cleared Nov 27, 2019
Hi-Fatigue G Bone Cement
K192379 · LOD
Osartis GmbH
Orthopedic · 89d
Cleared Nov 27, 2019
Rhythmia HDxTM Mapping System
K192438 · DQK
Boston Scientific Corporation
Cardiovascular · 82d
Cleared Nov 27, 2019
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter
K192468 · GBM
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 79d
Cleared Nov 27, 2019
Multi-modality workstation
K192519 · ONF
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 75d
Cleared Nov 27, 2019
Diagnostic Ultrasound System
K192791 · IYO
Edan Instruments, Inc.
Radiology · 58d
Cleared Nov 27, 2019
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
K192945 · HAW
7D Surgical, Inc.
Neurology · 40d
Cleared Nov 26, 2019
TRAUS Dental Handpieces
K182892 · EGS
Saeshin Precision Co., Ltd.
Dental · 407d
Cleared Nov 26, 2019
Physica KR Liner and SMR Reverse Humeral Liner
K190911 · JWH
Limacorporate
Orthopedic · 232d
Cleared Nov 26, 2019
FiberTak Button
K191426 · MBI
Arthrex, Inc.
Orthopedic · 181d
Cleared Nov 26, 2019
Heraeus Peripheral Guidewire
K191502 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 173d
Cleared Nov 26, 2019
OrthoGold
K191961 · PZL
Tissue Regeneration Technologies
General & Plastic Surgery · 126d
Cleared Nov 26, 2019
Peridot Intervertebral body fusion System
K192026 · MAX
Gbs Commonwealth Co., Ltd.
Orthopedic · 120d
Cleared Nov 26, 2019
Access PCT, Access PCT Calibrators
K192271 · PTF
Beckman Coulter, Inc.
Microbiology · 96d
Cleared Nov 26, 2019
HealthCXR
K192320 · QFM
Zebra Medical Vision, Ltd.
Radiology · 92d
Cleared Nov 26, 2019
Ion Endoluminal System
K192367 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 88d
Cleared Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
K192376 · PGI
Diasorin Molecular, LLC
Microbiology · 88d
Cleared Nov 26, 2019
Streamline MIS Spinal Fixation System
K192396 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 84d
Cleared Nov 26, 2019
ARIX Cannulated Screw System
K192417 · HWC
Jeil Medical Corporation
Orthopedic · 83d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · JWY
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 26, 2019
DePuy Synthes Trauma Screws
K192745 · HWC
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 57d