Search FDA 510(k) Database

6,850 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
15409–15432 of 174,061
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 163d
Cleared May 20, 2021
Vitals360 Multi-Vitals Mobile Monitor
K210086 · MWI
Vocare, Inc.
Cardiovascular · 127d
Cleared May 20, 2021
Xoran Workstation, Model 10050
K210257 · LLZ
Xoran Technologies, LLC
Radiology · 108d
Cleared May 20, 2021
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound...
K210476 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 90d
Cleared May 20, 2021
Actis DuoFix Hip Prosthesis- Collarless
K210581 · MEH
Depuy Ireland UC
Orthopedic · 83d
Cleared May 20, 2021
C-Qual M™ Breastboard
K211001 · IYE
Medtec, Inc. Dba Civco Medical...
Radiology · 48d
Cleared May 19, 2021
CUVIS-spine
K201569 · OLO
Curexo, Inc.
Orthopedic · 342d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576 · LYY
Pt. Universal Gloves
General Hospital · 342d
Cleared May 19, 2021
Turbett Instrument Pod
K202593 · FRG
Turbett Surgical, Inc.
General Hospital · 253d
Cleared May 19, 2021
TENS & EMS Device
K202866 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 233d
Cleared May 19, 2021
Contour Light CL-100
K202955 · OLI
Contour Research, LLC
General & Plastic Surgery · 231d
Cleared May 19, 2021
TECHFIT Patient-Specific Maxillofacial System
K203282 · JEY
Industrias Medicas Sampedro S.A.S
Dental · 194d
Cleared May 19, 2021
Overjet Dental Assist
K210187 · LLZ
Overjet, Inc.
Radiology · 114d
Cleared May 19, 2021
CINA CHEST
K210237 · QAS
Avicenna.Ai
Radiology · 111d
Cleared May 19, 2021
GII Spinal Fixation System
K210306 · NKB
Coligne AG
Orthopedic · 105d
Cleared May 19, 2021
Electrosurgical accessory
K210394 · FAS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 98d
Cleared May 19, 2021
Ohlendorf Clear Aligner
K210540 · NXC
Ohlendorf Appliance Laboratory
Dental · 84d
Cleared May 19, 2021
Steam-Dot Process Indicator
K210553 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 83d
Cleared May 19, 2021
Vereos PET/CT
K210880 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 56d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · JWY
Beckman Coulter, Inc.
Microbiology · 266d
Cleared May 18, 2021
BonOs Inject, Pedicle screw kits, Cement pusher
K202458 · LOD
Osartis GmbH
Orthopedic · 264d
Cleared May 18, 2021
Personal Lubricant Jelly
K202667 · NUC
Nantong Health & Beyond Hygienic...
Obstetrics & Gynecology · 246d
Cleared May 18, 2021
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
K202709 · GDW
Ningbo Verykind Medical Device Co., Ltd.
General & Plastic Surgery · 244d