Search FDA 510(k) Devices

5,410 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1009–1032 of 3,129
Not Cleared Sep 12, 2024
Hearing Aid Feature (HAF)
DEN230081 · SCR
Apple, Inc.
Ear, Nose, Throat · 283d
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
Cleared Sep 10, 2024
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for...
K234064 · OWQ
Surgical Instrument Service and...
Cardiovascular · 263d
Cleared Sep 09, 2024
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Sep 09, 2024
FoLix
K242349 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 32d
Cleared Sep 09, 2024
TriALTIS™ Spine System
K242042 · NKB
Medos International SARL
Orthopedic · 59d
Cleared Sep 09, 2024
Overjet Image Enhancement Assist
K241681 · QIH
Overjet, Inc.
Radiology · 90d
Cleared Sep 09, 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · NUH
Shenzhen Minghuangda Electronics Co.,...
Neurology · 90d