Search FDA 510(k) Devices

5,391 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
457–480 of 3,347
Cleared Nov 15, 2023
CoolSeal Trinity
K231012 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 219d
Cleared Nov 15, 2023
NSite Scoliosis Assessment App
K230463 · LDK
Nsite, Inc.
Physical Medicine · 267d
Cleared Nov 15, 2023
Curing Light, Model: MaxCure 9
K223414 · EBZ
Guilin Refine Medical Instrument Co.,...
Dental · 370d
Not Cleared Nov 15, 2023
Simple 2 Test
DEN200070 · QYA
Letsgetchecked Inc. (Formerly...
Microbiology · 1094d
Cleared Nov 14, 2023
Iconix Anchor
K233468 · MBI
Riverpoint Medical
Orthopedic · 21d
Cleared Nov 14, 2023
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · LRK
Prismatik Dentalcraft, Inc.
Dental · 32d
Cleared Nov 14, 2023
IPL Cooling Hair Removal Device
K232845 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 61d
Cleared Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
K232656 · OLP
Premier North America, Inc.
General & Plastic Surgery · 75d
Cleared Nov 14, 2023
MAGNETOM Avanto fit
K232494 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
K232461 · LZA
Kossan International Sdn Bhd
General Hospital · 91d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · OZN
Vela Operations USA
Microbiology · 124d
Cleared Nov 14, 2023
saremco print BRIDGETEC
K232050 · EBF
Saremco Dental AG
Dental · 127d
Cleared Nov 14, 2023
VitroPRO
K231783 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 151d
Cleared Nov 14, 2023
UniPearls® Embolic Microspheres
K231554 · KRD
Suzhou Haowei Medical Technology Co.,...
Gastroenterology & Urology · 168d
Cleared Nov 14, 2023
Broncho Videoscope System
K231521 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 172d
Cleared Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow,...
K231097 · NHA
Prismatik Dentalcraft, Inc.
Dental · 210d
Cleared Nov 14, 2023
QScout Lab
K230878 · GKZ
Ad Astra Diagnostics, Inc.
Hematology · 229d
Cleared Nov 14, 2023
BrainSpec Core™ Software
K230856 · LLZ
Brainspec, Inc.
Radiology · 230d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
K232509 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 87d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
K232488 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 88d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,...
K232241 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
Microwave Ablation System (BD-GT)
K232240 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
BriefCase-Quantification
K232083 · QIH
Aidoc Medical , Ltd.
Radiology · 123d