FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
6721–6744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 06, 2024
MSC SFM
K232543 · NDS
Yocon Biology Technology Company
Gastroenterology & Urology · 381d
Cleared Sep 06, 2024
Withings Sleep Rx
K231667 · MNR
Withings
Anesthesiology · 457d
Cleared Sep 05, 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN
Baxter Healthcare Corporation
General Hospital · 24d
Cleared Sep 05, 2024
Electric wheelchair (W3902)
K241723 · ITI
Zhejiang Richall Medical Technology...
Physical Medicine · 83d
Cleared Sep 05, 2024
Electric wheelchair (N3901)
K241721 · ITI
Zhejiang Richall Medical Technology...
Physical Medicine · 83d
Cleared Sep 05, 2024
Adaptix™ PEEK Interbody System with Nanotechnology
K241605 · MAX
Nanovis, LLC
Orthopedic · 93d
Cleared Sep 05, 2024
Fine Osteotomy™
K241356 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 114d
Cleared Sep 05, 2024
Cold Sore Device (QPZ-03)
K241155 · OKJ
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 133d
Cleared Sep 05, 2024
URUS System (DMG-SU100/URUS)
K240203 · FGB
Dyne Medical Group, Inc.
Gastroenterology & Urology · 224d
Cleared Sep 05, 2024
TRAQinform IQ
K233998 · LLZ
Aiq Global, Inc.
Radiology · 262d