Every 510(k), the day FDA posts it.

MediBot Needle Driver Uno

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6

Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

eXaSkin Plus

MagVenture Accelerated TMS (aTMS) Therapy System

C-beam

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)

da Vinci Firefly Imaging System

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel

Atmo Gas Capsule System

Spectrum-2

uMR Astra

Zenith Distal Access Long Sheath

Ion-C Navigation Instruments

Arc Adjustable Radial Cuff Compression Device

DePuy ATTUNE™ Knee System

AiSteth®

Apollo TMS Therapy System;Apollo light TMS Therapy System

InQwire Amplatz Guide Wire

Ulthera® System

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

pjur NATURE Touch, 100 ml

PanopticAI Vital Signs (1.6.1-22)

ROSA® Shoulder System

Boston 2910 (Boston 2910)

Sphincterotome

MSK Go

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

Nisus NPWT Canister 500-mL (CPC-500)

Wearable Breast Pump (Model S39)

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

Stelo Glucose Biosensor System

OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,

DCMhotbond zircon

BAC

Elos Accurate® Denture Fixation System

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

Mobility Scooter (Air Carbon)

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)

MAASTRO Rectal Applicator Set

The Circadia C300 System (C300)

Aquilion ONE (TSX-308A/TSX-306A) V2.0

WAVE PTA Balloon Catheter

ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

Blood Pressure Monitor (W06LT)

MR5 Activ Pro

Laport

LIAISON PLEX Gastrointestinal Flex Assay

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

Taperloc® Complete Hip Stem

FITBONE® TRANSPORT AND LENGTHENING SYSTEM

OrthoEasy Pal; OrthoEasy Pal Long Neck

FilmArray TF Control Panel M527

MOSES Raydar™

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

RhinAer+ Stylus

Coude Sleeved IC; Coude Plus Sleeved IC

G-CEM UNIVERSAL

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

BluEX Cervical Expandable Cage System

cobas liat CT/NG/MG nucleic acid test

NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)

uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super

Embryo Predict

UNiD™ Spine Analyzer (SW3002)

NovaLine Tubing Set for Hemodialysis (BL 124)

NxStage System One with NxView

Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+

KARL STORZ Laryngoscopes and Accessories

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Varion Thoracolumbar Fixation System

Manual Tissue Removal Device

Neurophet SCALE PET

Neurophet AQUA

Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)

medXion NEXUS

Jada System (Jada-2002)

Introcan Safety® Deep Access XL IV Catheter

Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

SubtleHD-CT (1.x)

TruSelect™ 2.6 Microcatheter

cobas liat CT/NG nucleic acid test

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Ventana® P/T Lumbar Interbody System

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

SubtleHD-PET (1.x)

RAYMO Mobile X-ray System (Model: RAYMO)