Search FDA 510(k) Devices

6,096 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
4921–4944 of 174,061
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880 · QJZ
Medtronic, Inc.
Cardiovascular · 164d
Cleared Sep 12, 2024
Surgikor Fixation One, Abutment Blanks and Abutments
K240803 · DZE
Surgikor, LLC
Dental · 171d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787 · DQY
Biotronik, Inc.
Cardiovascular · 174d
Cleared Sep 12, 2024
N7-S
K240168 · JFB
Nuga Medical Co., Ltd.
Physical Medicine · 234d
Cleared Sep 12, 2024
CoolSculpting Elite System
K233732 · OOK
Zeltiq Aesthetics, Inc. (Acquired by...
General & Plastic Surgery · 296d
Cleared Sep 12, 2024
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood...
K231982 · DTZ
Qura S.R.L
Cardiovascular · 435d
Cleared Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999 · PDJ
Shijiazhuang Hipro Biotechnology Co.,...
Chemistry · 892d
Cleared Sep 11, 2024
SonoBlock
K241954 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 70d
Cleared Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46...
K241745 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 85d
Cleared Sep 11, 2024
Signus Tetris™ St
K241438 · MAX
Signus Medizintechnik GmbH
Orthopedic · 113d
Cleared Sep 11, 2024
FETOLY-HEART
K241380 · IYN
Diagnoly
Radiology · 119d
Cleared Sep 11, 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · QEW
Surmodics,Inc.
Cardiovascular · 120d
Cleared Sep 11, 2024
Ultrasound Imaging System (LK128L)
K241161 · IYN
Leltek, Inc.
Radiology · 138d
Cleared Sep 11, 2024
HEALIX ADVANCE Knotless anchors
K241010 · MAI
Depuy Mitek
Orthopedic · 152d
Cleared Sep 11, 2024
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3,...
K241004 · HGX
Huizhou Lvb Maternal and Infant...
Obstetrics & Gynecology · 152d
Cleared Sep 11, 2024
Rx Knee System
K240683 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 183d
Cleared Sep 11, 2024
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K240271 · BZQ
Linshom Medical, Inc.
Anesthesiology · 224d
Cleared Sep 11, 2024
C&B NFH Hybrid
K232559 · EBF
Arum Dentistry Co., Ltd.
Dental · 385d
Cleared Sep 10, 2024
Option ELITE Vena Cava Filter System (352506070E 352506100E)
K242612 · DTK
Argon Medical Devices, Inc.
Cardiovascular · 7d
Cleared Sep 10, 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 95d
Cleared Sep 10, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 97d
Cleared Sep 10, 2024
ProPel SG3™ Surgical Gown
K241214 · FYA
Standard Textile Co., Inc.
General Hospital · 133d
Cleared Sep 10, 2024
Mobility Scooter
K240990 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 152d
Cleared Sep 10, 2024
LumiNE US
K240094 · QIH
Augmedit B.V.
Radiology · 242d