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
5353–5376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2024
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator...
K242567 · NUH
Changsha Anxiang Medical Technology...
Physical Medicine · 67d
Cleared Nov 04, 2024
Gemini Cervical Fusion Cage System
K242195 · ODP
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 101d
Cleared Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · NBW
Bionime Corporation
Chemistry · 243d
Cleared Nov 04, 2024
Tixel i (TXLI0001)
K240512 · ORZ
Novoxel , Ltd.
Ophthalmic · 256d
Cleared Nov 04, 2024
CDB Hospital ® Sterilization Wrap (70 gsm)
K240438 · FRG
Comercializadora Brever
General Hospital · 264d
Cleared Nov 01, 2024
Total Wrist Arthroplasty System (TWA)
K243381 · JWJ
Skeletal Dynamics, Inc.
Orthopedic · 2d
Cleared Nov 01, 2024
Legend X Desktop System
K243217 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 29d
Cleared Nov 01, 2024
Over-tube (TR-1108A)
K243091 · FED
Fujifilm Corporation
Gastroenterology & Urology · 32d
Cleared Nov 01, 2024
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37...
K242675 · KLE
Spident Co., Ltd.
Dental · 56d
Cleared Nov 01, 2024
DePuy ATTUNE™ Total Knee System
K242665 · OIY
Depuy Orthopedics, Inc.
Orthopedic · 58d
Cleared Nov 01, 2024
Breo Laser Hair Growth Comb (Scalp 3L)
K242620 · OAP
Shenzhen Breo Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
DRTECH Corporation
Radiology · 63d
Cleared Nov 01, 2024
Monkey Bars Pin to Bar External Fixation System
K242452 · KTT
Paragon 28, Inc.
Orthopedic · 74d
Cleared Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™...
K242393 · HQD
Acuity Polymers, Inc.
Ophthalmic · 80d
Cleared Nov 01, 2024
BD Vacutainer® One Use Holder
K242320 · JKA
Becton, Dickinson and Company
General Hospital · 88d
Cleared Nov 01, 2024
EXPERT - Flexible Joint Fixation System
K242311 · HTN
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 88d
Cleared Nov 01, 2024
SC+ Hemodialysis Device (SC-14269)
K242269 · ONW
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 92d
Cleared Nov 01, 2024
VersaCross™ RF Wire
K242076 · DXF
Baylis Medical Company
Cardiovascular · 108d
Cleared Nov 01, 2024
Prophecy Surgical Planning System
K241999 · HSN
Wright Medical Technology, Inc....
Orthopedic · 115d
Cleared Nov 01, 2024
Affera Integrated Mapping System
K241828 · DQK
Medtronic, Inc.
Cardiovascular · 130d
Cleared Nov 01, 2024
ORTIV (ORTIV-BL, ORTIV-WH)
K241646 · GEX
Mvitro Co., Ltd.
General & Plastic Surgery · 147d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Nov 01, 2024
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · GAG
Covidien (Part of Medtronic)
General & Plastic Surgery · 214d
Cleared Nov 01, 2024
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514 · KOB
Applied Medical Technology, Inc.
Gastroenterology & Urology · 253d