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
7969–7992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 31, 2024
MightySat -OTC
K214115 · OLK
Masimo Corporation
Anesthesiology · 762d
Cleared Jan 30, 2024
Ziehm Vision FD
K240020 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Jan 30, 2024
VIVA combo RF System (VIVA combo RF System)
K234140 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 32d
Cleared Jan 30, 2024
VariTrax Sternal CircumFixation System
K232986 · JDQ
Circumfix Solutions, Inc.
Orthopedic · 130d
Cleared Jan 30, 2024
G-Vitri™ Vitrification Freeze Media
K232942 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 132d
Cleared Jan 30, 2024
E3D™-A Interbody System
K232432 · OVD
Evolution Spine
Orthopedic · 172d
Cleared Jan 30, 2024
DermRays Revive
K231910 · GEX
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 30, 2024
Redemption Duo Hindfoot Nail System
K231343 · HSB
Vilex, LLC
Orthopedic · 266d
Cleared Jan 29, 2024
Rebuilder Nerve Guidance Conduit
K230794 · JXI
Celestray Biotech Company, LLC.,
Neurology · 313d
Cleared Jan 28, 2024
Gem Flow Now (GEM2770-FN)
K233394 · IYN
Synovis Micro Companies Alliance
Cardiovascular · 117d
Cleared Jan 27, 2024
Epilaser Pro
K233224 · GEX
Epilady 2000, LLC
General & Plastic Surgery · 121d
Cleared Jan 26, 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · KNT
Boehringer Laboratories
Gastroenterology & Urology · 28d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d