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
13681–13704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2022
Cardiovascular Angiography System
K220311 · OWB
Allengers Medical Systems Limited
Radiology · 90d
Cleared May 03, 2022
LINK Endo-Model EVO Knee System
K220628 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 60d
Cleared May 03, 2022
Surgical and Prosthetic Trays
K220791 · KCT
Dentsply Sirona
General Hospital · 46d
Cleared May 03, 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
K221010 · MUD
Vioptix, Inc.
General & Plastic Surgery · 28d
Cleared May 02, 2022
Liver Suite
K211180 · JAK
GE Medical Systems SCS
Radiology · 377d
Cleared May 02, 2022
ALPHALOK™ Plating System
K212348 · HRS
Vilex, LLC
Orthopedic · 278d
Cleared May 02, 2022
Arthrx Fracture Plates
K213837 · HRS
Arthrex, Inc.
Orthopedic · 144d
Cleared May 02, 2022
ExactechGPS® System
K213877 · OLO
Blue Ortho
Orthopedic · 140d
Cleared May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared May 02, 2022
ARx Modular Spinal System
K220341 · NKB
Life Spine, Inc.
Orthopedic · 84d
Cleared Apr 30, 2022
Ultiri Measurement System
K220243 · DQK
Abbott Medical
Cardiovascular · 92d
Cleared Apr 29, 2022
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956 · DHN
Zeus Scientific, Inc.
Immunology · 654d
Cleared Apr 29, 2022
Alinity m STI Assay
K202977 · QEP
Abbott Molecular, Inc.
Microbiology · 576d
Cleared Apr 29, 2022
Bindex BI-2
K211350 · MUA
Bone Index Finland , Ltd.
Radiology · 361d
Cleared Apr 29, 2022
Disposable Surgical Isolation Gown
K212422 · FYC
Crown Name Disposable Hygiene...
General Hospital · 268d
Cleared Apr 29, 2022
BONREE Nelaton Catheter
K212430 · EZD
Bonree Medical Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Apr 29, 2022
Safety Pen Needle for Single Use, Insulin Pen Needles
K212514 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 262d
Cleared Apr 29, 2022
SteriTite Container System with MediTray Products
K212711 · KCT
Case Medical, Inc.
General Hospital · 246d
Cleared Apr 29, 2022
Monarch Platform, Urology
K213334 · FGB
Auris Health, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 29, 2022
TIA Tip, Cariosity, Transillumination Accessory Tip
K213482 · NTK
D4D Technologies, LLC
Dental · 182d
Cleared Apr 29, 2022
BodyTom 64
K213649 · JAK
Neurologica Corporation
Radiology · 161d
Cleared Apr 29, 2022
FreedomEdge Syringe Infusion System
K214045 · FRN
Repro-Medical System, Inc., Dba Koru...
General Hospital · 123d
Cleared Apr 29, 2022
Camber Spine Navigation System
K220038 · OLO
Camber Spine Technologies
Orthopedic · 114d
Cleared Apr 29, 2022
LISA Laser Surgical Fibers
K220189 · GEX
Omni-Guide Holdings, Inc.
General & Plastic Surgery · 95d