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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
1681–1704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2025
InnoClip Clip Applier
K253781 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 26d
Cleared Dec 22, 2025
Instylla Delivery Kit
K253769 · FMF
Instylla, Inc.
General Hospital · 27d
Cleared Dec 22, 2025
Syndesmosis TightRope PRO
K253727 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 22, 2025
SKOUT system
K253664 · QNP
Iterative Health
Gastroenterology & Urology · 32d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 22, 2025
Theracor
K253339 · KGN
Stimlabs, LLC
General & Plastic Surgery · 83d
Cleared Dec 22, 2025
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 84d
Cleared Dec 22, 2025
EmbraceMini
K252981 · LEL
Empatica S.R.L.
Neurology · 96d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 22, 2025
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
K252743 · GAM
Ethicon, Inc.
General & Plastic Surgery · 116d
Cleared Dec 22, 2025
LacertaMatrix
K252673 · KGN
Lacerta Life Science
General & Plastic Surgery · 119d
Cleared Dec 22, 2025
Portable oxygen concentrator (JLO-190P)
K252616 · CAW
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 125d
Cleared Dec 22, 2025
aprevo® cervical plating system
K252611 · KWQ
Carlsmed, Inc.
Orthopedic · 126d
Cleared Dec 22, 2025
Lumify Diagnostic Ultrasound System
K252557 · IYN
Philips Ultrasound, LLC
Radiology · 131d
Cleared Dec 22, 2025
AccurECG Analysis System (v2.0)
K252361 · DPS
Accurkardia, Inc.
Cardiovascular · 146d
Cleared Dec 22, 2025
RayStation (2024A SP3)
K252109 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 168d
Cleared Dec 22, 2025
MC2 Portable X-ray System
K252068 · OWB
Oxos Medical
Radiology · 174d
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 194d
Cleared Dec 22, 2025
Oxygen Concentrator-P2-O5E
K251764 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 196d
Cleared Dec 22, 2025
DIMPLO Implant System
K251605 · DZE
DIMPLO, Ltd.
Dental · 209d
Cleared Dec 22, 2025
Power wheelchair
K251159 · ITI
Zhenjiang Assure Medical Equipment...
Physical Medicine · 251d
Cleared Dec 22, 2025
Tetra (TM-20)
K251105 · PKP
Emed Technologies Corporation
General Hospital · 255d
Cleared Dec 22, 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · FGE
Bioteque Corporation
Gastroenterology & Urology · 264d
Cleared Dec 22, 2025
BioticsAI
K250959 · IYN
Bioticsai, Inc.
Radiology · 266d