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

Elecsys EBV EBNA IgG

Elecsys EBV VCA IgG

Elecsys EBV IgM

Firstar Dental Electric Motor

Firstar Dental Handpieces

Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece

ErgoSteel (ES0001/696)

Multifunctional wheelchair (YJ-059)

Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)

Reclining wheelchair (YJ-013L)

YJ-K1K2 Wheelchair (YJ-013F)

LT Antibacterial Foam with Silver Dressing

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

Reusable SmartPeg

Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

AMI™ Plasma Cartridge, AMI™

NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR

Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Manual Wheelchair (H008, PCK7)

Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

GEN 4 JOY Wheelchair

PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

Manual Wheelchair (MS01);Manual Wheelchair (MA01)

Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)

Powder Free Nitrile Examination Gloves Non-Sterile Black

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

ICON 35; ICON 45; ICON 60; ICON 30FAF

RxSight® Insertion Device

Nitrile Disposable Examination Gloves

Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl

Manual Wheelchair (LW01108)

Helio Kids; Apex P

BD BACTEC FXI Culture System

Sterile Latex Powder Free Surgical Gloves

Manual Wheelchair (DY01903(2))

Derma-2

AllTest Strep A Rapid Test

Manual Wheelchair (7101L, 7102LHD)

IDS-iSYS Total Testosterone

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

SMART M-CELL Bone Marrow Concentration System

SMART M-CELL PRP Concentration System

Medical Imaging Calibration Feature (MICF)

K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))

Clungene RSV Antigen Rapid Test

Motor Handpiece and Control Unit (SDI10)

Manual Wheelchair (W50)

Syntex Exam Gloves

Cardinal Health Nitrile Examination Gloves Extended Cuff

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)

High speed air turbine handpiece

EmpowerRide NAVIGATOR

Star E900 Electric System

Lipids

Healgen® URS Test Strips

Manual Wheelchair (W45)

Manual Wheelchair (W47)

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

Manual Wheelchair (HM305-Air1, HM305-Air2)

Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Flexx Junior (FLX-J00, FLX-J50)

Midmark Dental Delivery System

AllTest Urinary Tract Infection Test

Disposable Vinyl Examination Gloves

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Alpha Endo Handpiece (Alpha Endo)

Heylo™ System

Manual Wheelchair (SYIV100A008)

Babio® Virus Transport Kit (Non-inactivating)

InnerView System

ACCUJECT Injector Set 2.1-1P (LP604590)

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Powder-Free Vinyl Exam Gloves, clear

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Motor and Apex Module (MaAM)

EnDrive (EnDriveUS)

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

MycoMEIA Aspergillus Assay

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

LymphaTech Mobile 3D Measuring Tool

ELEC ENGINE (Model: ISE-170L)

K5 Cart, K5 Mount, K5 Swing

TurbAlign

Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Integral Dental Unit

Digital Prism Correction Feature (DPCF)

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles