Search FDA 510(k) Devices

5,428 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2022–2022 ×
3,212 results
817–840 of 3,212
Cleared Oct 06, 2022
InfaTherm Disposable Infant Warming Mattress
K221653 · IMD
International Biomedical
Physical Medicine · 121d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Oct 06, 2022
A&D Medical UM-212BLE Blood Pressure Monitor
K212168 · DXN
A&D Company, Ltd.
Cardiovascular · 451d
Cleared Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · MQP
Arftx Medical, LLC
Orthopedic · 472d
Cleared Oct 05, 2022
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 26d
Cleared Oct 05, 2022
FaSet Fixation System
K222515 · MRW
Dio Medical Corporation
Orthopedic · 47d
Cleared Oct 05, 2022
VISIONAIR
K221892 · BXQ
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Oct 05, 2022
Cornisol
K221759 · LYX
Aurolab
Ophthalmic · 110d
Cleared Oct 05, 2022
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
K221128 · MAI
Arthrex, Inc.
Orthopedic · 170d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d
Cleared Oct 05, 2022
ClearCorrect System
K220140 · NXC
Clearcorrect, LLC
Dental · 260d
Cleared Oct 05, 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
K220138 · GEI
Led Spa
General & Plastic Surgery · 260d
Cleared Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · GJS
Coagusense, Inc.
Hematology · 399d
Cleared Oct 04, 2022
Route 92 Medical Full Length 070 Access System
K222743 · QJP
Route 92 Medical, Inc.
Neurology · 25d
Cleared Oct 04, 2022
TriVerse Total Knee Replacement System
K222380 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 60d
Cleared Oct 04, 2022
Hailie Sensor NF0107 & NF0108
K221994 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 90d
Cleared Oct 04, 2022
ROSA® Knee System
K221928 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 95d
Cleared Oct 04, 2022
CD HORIZON™ ASTUTE™ SPINAL SYSTEM
K221646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Oct 04, 2022
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR...
K221517 · LPL
INTEROJO, Inc.
Ophthalmic · 132d
Cleared Oct 04, 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use
K221079 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d