Search FDA 510(k) Database

6,990 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18601–18624 of 174,061
Cleared Apr 08, 2020
Voyant Maryland Fusion Device
K200598 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 30d
Cleared Apr 08, 2020
TCAT TKA Instrument Tray Set
K200632 · KCT
THINK Surgical, Inc.
General Hospital · 29d
Cleared Apr 07, 2020
The Optimotion Blue Total Knee System
K191084 · MBH
Optimotion Implants, LLC
Orthopedic · 349d
Cleared Apr 07, 2020
VERTICALE® Cervical System
K192013 · NKG
Silony Medical GmbH
Orthopedic · 253d
Cleared Apr 07, 2020
Innovision Audio
K193218 · LNH
Innovere Medical, Inc.
Radiology · 138d
Cleared Apr 07, 2020
BlueStar Rx
K193654 · MRZ
Welldoc, Inc.
Chemistry · 99d
Cleared Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 64d
Cleared Apr 07, 2020
HS40 Diagnostic Ultrasound System
K200339 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Apr 06, 2020
Neural Navigator
K191422 · HAW
Soterix Medical, Inc.
Neurology · 313d
Cleared Apr 06, 2020
Diode Laser Hair Removal System
K191970 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 257d
Cleared Apr 06, 2020
Straumann Screw-Retained Abutments
K192401 · NHA
Straumann USA, LLC
Dental · 216d
Cleared Apr 06, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500 · DXQ
Honsun (Nantong) Co., Ltd.
Cardiovascular · 207d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access...
K192558 · DQY
Mivi Neurovascular
Neurology · 202d
Cleared Apr 06, 2020
SensiCare PI and SensiCare PI Micro Surgical Gloves
K193217 · KGO
Medline Industries, Inc.
General Hospital · 137d
Cleared Apr 06, 2020
Irrigation Tubing with CO2 or Air
K193250 · OCX
Keymed (Medical and Industrial...
Gastroenterology & Urology · 133d
Cleared Apr 06, 2020
Origin™ Anterior Cervical Plate System
K193494 · KWQ
Orthopaedic & Spine Development
Orthopedic · 111d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs...
K200019 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 94d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K200025 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204 · GGZ
Nova Biomedical Corporation
Chemistry · 69d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · JWY
Liofilchem S. R. 1.
Microbiology · 60d
Cleared Apr 06, 2020
Tryptik Ti
K200312 · ODP
Spineart
Orthopedic · 60d
Cleared Apr 06, 2020
Akros Scruture Anchor LisFranc Repair Kit
K200361 · HTN
Akros Medical
Orthopedic · 52d