FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13273–13296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K221620 · MQB
Canon, Inc.
Radiology · 11d
Cleared Jun 13, 2022
Disposable Hemostatic Closure Clip Device
K220157 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 145d
Cleared Jun 13, 2022
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
K221081 · IZL
First Source, Inc.
Radiology · 62d
Cleared Jun 13, 2022
3M Filtek Supreme Flowable Restorative
K221695 · EBF
3M Company Espe Dental Products
Dental · 3d
Cleared Jun 12, 2022
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
K203208 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 590d
Cleared Jun 11, 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · NUH
Hivox Biotek, Inc.
Neurology · 29d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared Jun 10, 2022
EasyClip® and EasyClip® Xpress
K210582 · JDR
Stryker GmbH
Orthopedic · 469d
Cleared Jun 10, 2022
PAL System
K212024 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 346d
Cleared Jun 10, 2022
Armory Motion
K213097 · ILO
Pain Management Technologies, Inc.
Neurology · 259d
Cleared Jun 10, 2022
Extroducer Infusion Catheter System
K213442 · KRA
SmartWise Sweden AB
Cardiovascular · 228d
Cleared Jun 10, 2022
WesperO2
K213515 · DQA
Wesper, Inc.
Anesthesiology · 220d
Cleared Jun 10, 2022
Rune Labs Tremor Transducer System
K213519 · GYD
Rune Labs, Inc.
Neurology · 219d