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
8401–8424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2023
Neuronaute Plus
K231366 · GWQ
Bioserenity Sas
Neurology · 182d
Cleared Nov 09, 2023
TissueStat
K231277 · NBY
Durastat, LLC
General & Plastic Surgery · 190d
Cleared Nov 09, 2023
Cardio P1
K231150 · DPS
Bionet Co., Ltd.
Cardiovascular · 202d
Cleared Nov 09, 2023
Oxygen Concentrator
K230969 · CAW
Jiangsu Jumao X-Care Medical...
Anesthesiology · 218d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · QYT
ACON Laboratories, Inc.
Microbiology · 227d
Cleared Nov 09, 2023
BraveCX
K223754 · QFM
Bering, Ltd.
Radiology · 329d
Cleared Nov 09, 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K223682 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 336d
Cleared Nov 09, 2023
LILY Extension Tube and Needleless Connector
K222780 · FPA
Lily Medical Corporation
General Hospital · 421d
Cleared Nov 08, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · MBI
Healthium Medtech Limited
Orthopedic · 51d
Cleared Nov 08, 2023
NerivioInfinity
K232152 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 112d
Cleared Nov 08, 2023
da Vinci SP Surgical System
K231798 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 141d
Cleared Nov 08, 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U,...
K231773 · DTZ
Qura S.R.L
Cardiovascular · 145d
Cleared Nov 08, 2023
Contour ProtégéAI
K231765 · QKB
Mim Software, Inc.
Radiology · 145d
Cleared Nov 08, 2023
BriefCase-Quantification
K230534 · QIH
Aidoc Medical , Ltd.
Radiology · 254d
Cleared Nov 08, 2023
Cure Catheter Closed System
K230400 · EZD
Convatec, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 08, 2023
VS Tabletop Tonometer
K223739 · HKX
Medimaging Integrated Solution, Inc.
Ophthalmic · 329d
Cleared Nov 07, 2023
Axium Detachable Coil
K233420 · HCG
Micro Therapeutics Lnc. D/B/A Ev3...
Neurology · 28d
Cleared Nov 07, 2023
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical...
K232866 · GCJ
Jiangsu Channel Medical Device Co., Ltd.
General & Plastic Surgery · 53d
Cleared Nov 07, 2023
Disposable Sphincterotome
K232476 · KNS
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 83d
Cleared Nov 07, 2023
Peridot-EX Expandable Intervertebral Body Fusion System
K232292 · MAX
Gbs Commonwealth Co., Ltd.
Orthopedic · 98d
Cleared Nov 07, 2023
LOGIQ E10s, LOGIQ Fortis
K231989 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 125d
Cleared Nov 07, 2023
LOGIQ E10
K231966 · IYN
GE Medical Systems Ultrasound and...
Radiology · 127d
Cleared Nov 07, 2023
Biodegradable Medical surgical mask
K231155 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 197d
Cleared Nov 06, 2023
KARL STORZ ICG Imaging System
K232857 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 52d