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
10513–10536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2023
Renuvion® APR Handpiece
K230272 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 86d
Cleared Apr 27, 2023
ArtiSential Laparoscopic Instruments-Electrodes
K230539 · GEI
Livsmed, Inc.
General & Plastic Surgery · 59d
Cleared Apr 27, 2023
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke...
K230547 · GEI
Conmed Corporation
General Hospital · 58d
Cleared Apr 27, 2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with...
K230844 · JWH
Conformis, Inc.
Orthopedic · 30d
Cleared Apr 27, 2023
32HL512D, 31HN713D, 32HQ713D
K230845 · PGY
Lg Electronics.Inc
Radiology · 30d
Cleared Apr 27, 2023
Braun Skin i.expert
K230911 · OHT
Cyden Limited
General & Plastic Surgery · 27d
Cleared Apr 26, 2023
Endo Motor
K222548 · EKX
Shenzhen Perfect Medical Instruments...
Dental · 246d
Cleared Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS...
K222584 · FET
Olympus Medical Systems Corporation
Gastroenterology & Urology · 243d
Cleared Apr 26, 2023
Access PCT
K222996 · PTF
Beckman Coulter, Inc.
Microbiology · 210d
Cleared Apr 26, 2023
PYXIS 3D Titanium Cage System
K223868 · MAX
GS Medical Co., Ltd.
Orthopedic · 124d
Cleared Apr 26, 2023
SafeAir combi (SFR-combi-US)
K223932 · GEI
Lina Medical Aps
General Hospital · 117d
Cleared Apr 26, 2023
ArtiSential Laparoscopic Instruments-Electrodes
K230499 · GEI
Livsmed, Inc.
General & Plastic Surgery · 61d
Cleared Apr 26, 2023
MR DWI/FLAIR Measurement V1.0
K230552 · LLZ
Olea Medical
Radiology · 57d
Cleared Apr 26, 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · MXD
Medtronic, Inc.
Cardiovascular · 57d
Cleared Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K230829 · NUH
Chongqing Rob Linka Science and...
Neurology · 30d
Cleared Apr 25, 2023
NITRO Interbody Fusion Cage System Family
K220513 · ODP
Ctl Medical Corporation
Orthopedic · 427d
Cleared Apr 25, 2023
Ceevra Reveal 3
K222676 · QIH
Ceevra, Inc.
Radiology · 231d
Cleared Apr 25, 2023
Wallaby 017 Micro Catheter
K223139 · KRA
Wallaby Medical
Neurology · 203d
Cleared Apr 25, 2023
MiVu™ Esophageal Endo Cap
K230056 · QIS
Diversatek Healthcare
Gastroenterology & Urology · 106d
Cleared Apr 25, 2023
TMINI™ Miniature Robotic System
K230202 · OLO
THINK Surgical, Inc.
Orthopedic · 90d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204 · HRS
Vilex, LLC
Orthopedic · 90d
Cleared Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218 · NHA
Dental Direkt GmbH
Dental · 89d
Cleared Apr 25, 2023
iCAC Device
K230223 · JAK
Bunkerhill, Inc.
Radiology · 89d
Cleared Apr 25, 2023
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
K230503 · DRF
Boston Scientific
Cardiovascular · 60d