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
7681–7704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Feb 02, 2024
AllPEP
K233855 · BWF
Enchant Tek Co. , Ltd.
Anesthesiology · 59d
Cleared Feb 02, 2024
Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
K233756 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 70d
Cleared Feb 02, 2024
OIC FLEX-FIX™ System
K233531 · HTN
Orthopaedic Implant Company
Orthopedic · 92d
Cleared Feb 02, 2024
CVAC Aspiration System + CVAC Image Processor
K233472 · FED
Calyxo, Inc.
Gastroenterology & Urology · 100d
Cleared Feb 02, 2024
PiXel8-Reveal
K233143 · GEX
Rohrer Aesthetics
General & Plastic Surgery · 128d
Cleared Feb 02, 2024
VitalDetect
K231625 · FLL
Wellvii, Inc.
Cardiovascular · 245d
Cleared Feb 02, 2024
5008X Hemodialysis System
K231534 · KDI
Fresenius Medical Care
Gastroenterology & Urology · 248d
Cleared Feb 02, 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Feb 02, 2024
Corplex P / Theracor P / Allacor P
K231325 · KGN
Stimlabs, LLC
General & Plastic Surgery · 270d
Cleared Feb 02, 2024
Myoaligner Appliance
K230548 · MQC
Myohealth Technologies, LLC
Dental · 339d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · DQY
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Feb 01, 2024
Resonic Rapid Acoustic Pulse Device
K233804 · GEX
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 64d
Cleared Feb 01, 2024
Surgical Gown (40083)
K233183 · FYA
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 126d
Cleared Feb 01, 2024
Kelowna GYN and Crook Prostate Templates
K232949 · JAQ
Varian Medical Systems, Inc.
Radiology · 134d
Cleared Feb 01, 2024
Augmented Reality Application
K232339 · LLZ
Sira Medical, Inc.
Radiology · 181d
Cleared Feb 01, 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 195d
Cleared Feb 01, 2024
CAAS MR Solutions
K232007 · LLZ
Pie Medical Imaging BV
Radiology · 210d
Cleared Feb 01, 2024
BTL-99-OC
K230657 · QCI
BTL Industries, Inc.
Neurology · 329d
Cleared Jan 31, 2024
Clearblue® Early Detection Pregnancy Test
K240025 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 28d
Cleared Jan 31, 2024
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S )
K240004 · DYB
Circa Scientific, Inc.
Cardiovascular · 29d
Cleared Jan 31, 2024
Microwave Ablation Device (Exceed S10U)
K233140 · NEY
Hygea Medical Technology Co., Ltd.
General & Plastic Surgery · 126d
Cleared Jan 31, 2024
Digital Thermometer, Model T28, T28L
K232678 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 152d
Cleared Jan 31, 2024
CEPHX- Cephalometric Analysis Software
K231396 · LLZ
Orca Dental AI , Ltd.
Radiology · 261d