Search FDA 510(k) Database

6,722 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12505–12528 of 174,061
Cleared May 04, 2022
MyKnee R Pin Positioners
K220705 · JWH
Medacta International S.A.
Orthopedic · 55d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared May 03, 2022
MVision AI Segmentation
K212915 · QKB
MVision AI
Radiology · 232d
Cleared May 03, 2022
exoplan
K213302 · LLZ
Exocad GmbH
Radiology · 211d
Cleared May 03, 2022
ECHOLASER X4
K213594 · GEX
Elesta S.P.A
General & Plastic Surgery · 172d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
K220013 · JOY
Scopio Labs , Ltd.
Hematology · 119d
Cleared May 03, 2022
ECGenius System
K220306 · DQK
Cath Vision Aps
Cardiovascular · 90d
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