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
12985–13008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 16, 2022
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible...
K220399 · EOQ
OTU Medical, Inc.
Ear, Nose, Throat · 125d
Cleared Jun 16, 2022
Dentis s-Clean Abutment Mini
K220440 · NHA
Dentis Co., Ltd.
Dental · 120d
Cleared Jun 16, 2022
Disposable Vinyl Examination Glove
K220469 · LYZ
Chifeng Huawei Medical...
General Hospital · 118d
Cleared Jun 16, 2022
Straumann TLX Variobase C
K220878 · NHA
Institut Straumann AG
Dental · 83d
Cleared Jun 16, 2022
TC Gloves
K221186 · LZA
Thanh Cong Pharmaceutical and Trading...
General Hospital · 52d
Cleared Jun 16, 2022
1st Glove Blue Nitrile Examination Gloves Powder Free
K221226 · LZA
Koove Iot Pvt. , Ltd.
General Hospital · 49d
Cleared Jun 16, 2022
Wireless Digital Flat Panel Detector
K221345 · MQB
Iray Technology Taicang , Ltd.
Radiology · 38d
Cleared Jun 15, 2022
EEG-acp
K212325 · GYB
Somnomedics GmbH
Neurology · 324d
Cleared Jun 15, 2022
ZQuiet Advance
K213088 · LRK
Sleeping Well, LLC
Dental · 264d
Cleared Jun 15, 2022
VITROS AFP
K213626 · LOJ
Ortho-Clinical Diagnostics
Immunology · 210d
Cleared Jun 15, 2022
SurgiCase Viewer
K213684 · LLZ
Materialise NV
Radiology · 205d
Cleared Jun 15, 2022
QardioArm 2
K220106 · DXN
Qardio, Inc.
Cardiovascular · 154d
Cleared Jun 15, 2022
MEDOJECT fine Pen Needles
K220614 · FMI
Chirana T. Injecta
General Hospital · 104d
Cleared Jun 15, 2022
Dia-X Bond Universal
K220804 · KLE
DiaDent Group International
Dental · 89d
Cleared Jun 15, 2022
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System...
K221448 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Jun 14, 2022
Yomi Robotic System with YomiPlan Go
K211466 · PLV
Neocis, Inc.
Dental · 399d
Cleared Jun 14, 2022
Logic Hd camera head green, System green
K212808 · FET
Richard Wolf Medical Instruments...
General & Plastic Surgery · 284d
Cleared Jun 14, 2022
EVA NEXUS Ophthalmic Surgical System
K213467 · HQC
D.O.R.C. Dutch Ophthalmic Research...
Ophthalmic · 229d
Cleared Jun 14, 2022
Zsquare ENT-Flex Endoscope
K220004 · EOB
Zsquare, Ltd.
Ear, Nose, Throat · 161d
Cleared Jun 14, 2022
Disposable Surgical Face Mask (M663BE, M663BT)
K220550 · FXX
Makrite Industries, Inc.
General Hospital · 109d
Cleared Jun 14, 2022
PERF-GEN Pulsatile Perfusion Solution
K221386 · KDL
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Jun 14, 2022
BEL-GEN Cold Storage Solution
K221387 · KDL
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Jun 14, 2022
ACUSON Sequoia Diagnostic Ultrasound System
K221500 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d