510(k) Device Clearances

Waypoint GPS

Waypoint Orthopedics, Inc.

Polaris X™ Unidirectional Steerable Diagnostic Catheter

Boston Scientific Corporation

Augment Off-Axis Instrument System

Zimmer, Inc.

Defendo Fujifilm 700 Single Use Cleaning Adapter

Steris Corparation

AMSCO 700 Steam Sterilizer

STERIS Corporation

FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F000

Fresenius Medical Care Renal Therapies Group, LLC

NeuroQuant PET

Cortechs Labs, Inc.

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

Shanghai AnQing Medical Instrument Co., Ltd.

Contour ProtégéAI

Mim Software, Inc.

CELERITY HP Indicator Tape (PCC077)

Steris

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diff

Ganshorn Medizin Electronic GmbH

PuraStat-RM

3-D Matrix, Inc.

Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

Quara S.R.L.

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citr

Brightway Holdings Sdn. Bhd.

Aesculap AICON Container

Aesculap, Inc.

XACT ACE Robotic System

Xact Robotics, Ltd.

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Guangzhou Red Pine Medical Instrument Co., Ltd.

Vapotherm Aerosol Adapter AAA-2

Vapotherm, Inc.

Fitbit Irregular Rhythm Notifications

Fitbit, Inc.

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

Ventana Medical Systems, Inc.

Respiree Cardio- Respiratory Monitor System

Respiree Pte, Ltd.

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

Inion OY

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System

L&K BIOMED Co., Ltd.

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI

Philips Medizin Systeme Böblingen GmbH

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Olympus Medical Systems Corporation

Solas OR

Cirdan Imaging, Ltd.

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Tec

Smith & Nephew Medical, Ltd.

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

Kyocera Medical Technologies, Inc.

Kneu Platform (V2)

Kneu Health Digital , Ltd.

ORiGO System

Bien-Air Surgery SA