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
8377–8400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2023
CLEARFIL Universal Bond Quick 2
K231039 · KLE
Kuraray Noritake Dental, Inc.
Dental · 245d
Cleared Dec 13, 2023
Power Wheelchair (N5909)
K230964 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 252d
Cleared Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852 · GGP
Instrumentation Laboratory Company
Hematology · 260d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 271d
Cleared Dec 12, 2023
TriALTIS™ Spine System
K233684 · NKB
Medos International SARL
Orthopedic · 26d
Cleared Dec 12, 2023
Intri24 Introducer Sheath (52-101)
K233646 · DYB
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
K233645 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Dec 12, 2023
TeleScan
K233634 · LLZ
Bb Imaging
Radiology · 29d
Cleared Dec 12, 2023
ARx MIS Spinal Screw System
K233455 · NKB
Life Spine, Inc.
Orthopedic · 53d
Cleared Dec 12, 2023
Aygün Sterilization Container Systems
K233222 · KCT
Aygun Surgical Instruments Co., Inc.
General Hospital · 75d
Cleared Dec 12, 2023
Sterile Hypodermic Needles for Single Use
K233037 · FMI
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 78d
Cleared Dec 12, 2023
SIRA™ RFA Electrosurgical Device
K232947 · GEI
Innoblative Designs, Inc.
General & Plastic Surgery · 83d
Cleared Dec 12, 2023
Insulia Bolus Companion
K232451 · NDC
Voluntis Sa.
Chemistry · 120d
Cleared Dec 12, 2023
Signature™ ONE System
K232425 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 123d
Cleared Dec 12, 2023
Ziehm Solo FD
K231669 · OWB
Ziehm Imaging GmbH
Radiology · 187d
Cleared Dec 12, 2023
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™...
K230872 · MAX
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 257d
Cleared Dec 11, 2023
Nio Color 8MP (MDNC-8132)
K233693 · PGY
Barco N.V.
Radiology · 24d
Cleared Dec 11, 2023
FARADRIVE™ Steerable Sheath
K233248 · DRA
Boston Scientific Corporation
Cardiovascular · 74d
Cleared Dec 11, 2023
24HR513C
K232985 · PGY
Lg Electronics.Inc
Radiology · 80d
Cleared Dec 11, 2023
Wrist Blood Pressure Monitor
K232815 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 89d
Cleared Dec 11, 2023
Hygenix
K232797 · FXX
Shenzhen Hygenix Industrial Co., Ltd.
General Hospital · 90d
Cleared Dec 11, 2023
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and...
K232303 · MBH
Depuy Ireland UC
Orthopedic · 132d
Cleared Dec 11, 2023
INTELLIO SHIFT System
K232290 · GEI
ArthroCare Corporation
General & Plastic Surgery · 132d
Cleared Dec 11, 2023
Transpara Density 1.0.0
K232096 · QIH
Screenpoint Medical B.V.
Radiology · 151d