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
6121–6144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2024
ADAS 3D
K240791 · QIH
Adas3D Medical S.L.
Radiology · 171d
Cleared Sep 09, 2024
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
K240697 · QDQ
See-Mode Technologies Pte, Ltd.
Radiology · 179d
Cleared Sep 09, 2024
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 222d
Cleared Sep 09, 2024
Pitkar Spinal Pedicle Screw System
K240233 · NKB
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 224d
Cleared Sep 08, 2024
PM2 System and ECGuide Connector
K240486 · LJS
Piccolo Medical, Inc.
Cardiovascular · 201d
Cleared Sep 06, 2024
TMC Compression Implant System
K242415 · JDR
Treace Medical Concepts
Orthopedic · 22d
Cleared Sep 06, 2024
nextaro® va, 15mm, 5µm
K241976 · LHI
Sfm Medical Devices GmbH
General Hospital · 63d
Cleared Sep 06, 2024
FemChec Controlled Saline-Air Device (FCD-250)
K241693 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 86d
Cleared Sep 06, 2024
COPRO 3
K241672 · GEX
Amt Engineering Co., Ltd.
General & Plastic Surgery · 87d
Cleared Sep 06, 2024
DD Hybridlayer (multicolored zirconia)
K241579 · EIH
Dental Direkt GmbH
Dental · 95d
Cleared Sep 06, 2024
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
K241552 · MRD
Mentor Worldwide, LLC
General & Plastic Surgery · 98d
Cleared Sep 06, 2024
Access Syphilis
K241427 · LIP
Beckman Coulter, Inc.
Microbiology · 109d
Cleared Sep 06, 2024
Orchid Safety Release Valve™
K241415 · QOI
Linear Health Sciences, LLC
General Hospital · 112d
Cleared Sep 06, 2024
IB3D™ PL Spinal System
K241164 · MAX
Medicrea International S.A.S....
Orthopedic · 133d
Cleared Sep 06, 2024
SafeCross Vascular Introducer System (4001)
K240600 · DYB
East End Medical I, LLC
Cardiovascular · 186d
Cleared Sep 06, 2024
uAI Portal
K240411 · QIH
Shanghai United Imaging Intelligence...
Radiology · 207d
Cleared Sep 06, 2024
ACS® LD FB Knee System
K234044 · JWH
Implantcast GmbH
Orthopedic · 260d
Cleared Sep 06, 2024
COSINE™ Spacer
K234035 · MAX
Globus Medical, Inc.
Orthopedic · 261d
Cleared Sep 06, 2024
Mucosal Impedance Measurement System
K233974 · QIS
Alandra Medical Sapi DE CV
Gastroenterology & Urology · 266d
Cleared Sep 06, 2024
Luvis Chair (LC700C)
K233921 · KLC
Dentis Co., Ltd.
Dental · 268d
Cleared Sep 06, 2024
VISULAS combi
K233911 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 269d
Cleared Sep 06, 2024
Nordica PV Cryo Mapping Catheter
K233900 · DRF
Synaptic Medical Corporation
Cardiovascular · 270d
Cleared Sep 06, 2024
T2 Plus
K233806 · OAS
Osstem Implant Co., Ltd.
Radiology · 282d
Cleared Sep 06, 2024
Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
K232996 · MAX
Shanghai Iatrical-Ti Technologies CO...
Orthopedic · 350d