FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7537–7560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · DFH
Sebia
Immunology · 267d
Cleared Feb 23, 2024
Electronic Peak Flow Meter
K230423 · BZH
Taian Dalu Medical Instrument Co., Ltd.
Anesthesiology · 371d
Cleared Feb 22, 2024
Oligio X
K240313 · GEI
Wontech Co., Ltd.
General & Plastic Surgery · 20d
Cleared Feb 22, 2024
R501 - R502 aortic root cannulae with and without vent line (R501-15:...
K240193 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Feb 22, 2024
1688 4K Camera System with Advanced Imaging Modality
K240174 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 30d
Cleared Feb 22, 2024
Treace Medical Systems (TMC) Plating System
K240173 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
K233996 · OHV
Ulthera, Inc.
General & Plastic Surgery · 66d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 90d
Cleared Feb 22, 2024
Revolution Ascend Sliding
K233749 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 92d
Cleared Feb 22, 2024
Segmental Plating System (SPS)
K233640 · KWQ
Alphatec Spine, Inc.
Orthopedic · 101d
Cleared Feb 22, 2024
MESHEET
K233544 · NXC
Dentis Co., Ltd.
Dental · 111d
Cleared Feb 22, 2024
Quiver Aspiration Pump
K232831 · BTA
Anoxia Medical, Inc.
General & Plastic Surgery · 162d
Cleared Feb 22, 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163 · MQE
Zhejiang Horizon Medical Technology...
Obstetrics & Gynecology · 216d
Cleared Feb 22, 2024
Serafin®
K232074 · NXC
Tns Co., Ltd.
Dental · 225d
Cleared Feb 22, 2024
MultiPulse HoPLUS
K231876 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 241d
Cleared Feb 22, 2024
Vaginal Tactile Ultrasound Imager
K231875 · HIR
Advanced Tactile Imaging, Inc.
Obstetrics & Gynecology · 241d
Cleared Feb 22, 2024
NanoDrop Lancet
K223826 · FMK
Drawbridge Health, Inc.
General & Plastic Surgery · 428d
Cleared Feb 22, 2024
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
K214037 · ITH
Ergo-Flex Technologies, LLC
Physical Medicine · 791d
Cleared Feb 21, 2024
ProCinch, QuadCinch
K240194 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Feb 21, 2024
HD60 Series Ultrasound Diagnostic System
K233439 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 128d
Cleared Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K233325 · HQD
Visionary Optics, LLC
Ophthalmic · 145d
Cleared Feb 21, 2024
ROSA® Shoulder System
K233199 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 146d
Cleared Feb 21, 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 187d
Cleared Feb 21, 2024
BLUEPRINT™ Patient Specific Instrumentation
K232265 · PHX
Tornier S.A.S.
Orthopedic · 205d