Search FDA 510(k) Devices

5,377 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2022–2022 ×
3,212 results
25–48 of 3,212
Cleared Dec 29, 2022
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K221333 · HWC
Acumed, LLC
Orthopedic · 234d
Cleared Dec 29, 2022
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical...
K220935 · FKX
Iren-Medical, Ltd.
Gastroenterology & Urology · 273d
Cleared Dec 29, 2022
Multi-Parameter Patient Monitor
K211619 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 582d
Cleared Dec 29, 2022
EndoPATx
K211557 · DQK
Itamar Medical , Ltd.
Cardiovascular · 589d
Cleared Dec 28, 2022
Medussa-PL Cage
K223654 · MAX
Medyssey USA, Inc.
Orthopedic · 22d
Cleared Dec 28, 2022
BD AutoShield Duo™ Pen Needle
K223286 · FMI
Becton, Dickinson and Company
General Hospital · 64d
Cleared Dec 28, 2022
StageOne™ Select Hip Cement Spacer Molds
K222760 · MBB
Biomet, Inc.
Orthopedic · 106d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Dec 28, 2022
nView s1 with nav option
K221344 · OWB
Nview Medical
Radiology · 233d
Cleared Dec 27, 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...
K223094 · DQK
Abbott Medical
Cardiovascular · 88d
Cleared Dec 27, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K222978 · QUW
Xiros, Ltd.
Orthopedic · 90d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · DHA
Beckman Coulter, Inc.
Chemistry · 174d
Cleared Dec 27, 2022
IOB Warming Blankets
K221669 · DWJ
Iob Medical, Inc.
Cardiovascular · 201d
Cleared Dec 27, 2022
R:GEN
K220974 · HQF
Lutronic Vision, Inc.
Ophthalmic · 267d
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K223565 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
K223442 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 39d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · CDD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Dec 23, 2022
Xenoview VDP
K223071 · LLZ
Polarean, Inc.
Radiology · 84d
Cleared Dec 23, 2022
Leg Massager RF-ALM070
K222924 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 88d
Cleared Dec 23, 2022
ShiNeo Silicone Implant
K222748 · MIB
Shineo Technology Co., Ltd.
General & Plastic Surgery · 102d
Cleared Dec 23, 2022
Smartpump 3.0 Double Electric Breast Pump
K222726 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 106d
Cleared Dec 23, 2022
Visant Medical Canalicular Plug
K222164 · LZU
Visant Medical, Inc.
Ophthalmic · 155d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765 · JXM
Roche Diagnostics
Toxicology · 189d
Cleared Dec 23, 2022
CIMILRE Free-T2 Plus
K221708 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 193d