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
22777–22800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2019
The JASPER Spinal Fixation System II
K190762 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 86d
Cleared Jun 19, 2019
Republic Spine Restore Cervical Interbody Fusion System
K190889 · ODP
Republic Spine, LLC
Orthopedic · 75d
Cleared Jun 19, 2019
Multix Fusion Max
K191418 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 18, 2019
Bovine Pericardial Tissue Patch
K182493 · FTM
Tisgenx
General & Plastic Surgery · 280d
Cleared Jun 18, 2019
Med-link Temperature Probes
K182667 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 266d
Cleared Jun 18, 2019
NanoKnife System
K183385 · OAB
Angiodynamics
General & Plastic Surgery · 194d
Cleared Jun 18, 2019
Torpedo Gelatin Foam
K183578 · KRD
Biosphere Medical, S.A.
Cardiovascular · 179d
Cleared Jun 18, 2019
QLAB Advanced Quantification Software 13
K190913 · LLZ
Philips Health Care
Radiology · 71d
Cleared Jun 18, 2019
Stryker MIS and Footed Attachments
K191049 · HBE
Stryker Corporation
Neurology · 60d
Cleared Jun 18, 2019
Aneroid Type Blood Pressure Kit
K191209 · DXQ
Dongguan Mars Medical Products Co., Ltd.
Cardiovascular · 43d
Cleared Jun 17, 2019
GALILEO Spine Alignment Monitoring System
K182524 · OLO
MiRus, LLC
Orthopedic · 277d
Cleared Jun 17, 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · EYB
Cook Incorporated
Gastroenterology & Urology · 263d
Cleared Jun 17, 2019
IDS SHBG
K190121 · CDZ
Immunodiagnostic Systems , Ltd.
Chemistry · 143d
Cleared Jun 17, 2019
MRI Compatibility for Existing Straumann Dental Implant Systems
K190662 · DZE
Straumann USA, LLC
Dental · 94d
Cleared Jun 17, 2019
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
K190663 · BSN
PAJUNK GmbH Medizintechnologie
Anesthesiology · 94d
Cleared Jun 17, 2019
LxHA PEEK Lateral IBF System
K190684 · MAX
Innovasis, Inc.
Orthopedic · 91d
Cleared Jun 17, 2019
Q-Switched Nd: YAG Laser System
K190936 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 68d
Cleared Jun 17, 2019
FlowTriever Retrieval/Aspiration System
K191368 · QEW
Inari Medical
Cardiovascular · 26d
Cleared Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
K190010 · NRY
Penumbra, Inc.
Neurology · 164d
Cleared CT Jun 14, 2019
VIVO
K183195 · DQK
Catheter Precision, Inc.
Cardiovascular · 207d
Cleared Jun 14, 2019
Trio-CT Triple Lumen Catheter
K183219 · NIE
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 206d
Cleared Jun 14, 2019
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
K183263 · PEM
Unipack Medical Corporation
General & Plastic Surgery · 203d
Cleared Jun 14, 2019
Medline Digital Rectal Thermometer Sheath
K183431 · FLL
Medline Industries, Inc.
General Hospital · 185d
Cleared Jun 14, 2019
CLARITY II Laser System
K183566 · GEX
Lutronic Corporation
General & Plastic Surgery · 175d