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

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 PRP Concentration System

SMART M-CELL Bone Marrow 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))

Motor Handpiece and Control Unit (SDI10)

Clungene RSV Antigen Rapid Test

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

EmpowerRide NAVIGATOR

High speed air turbine handpiece

Star E900 Electric System

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)

Lipids

Healgen® URS Test Strips

Manual Wheelchair (W45)

Manual Wheelchair (W47)

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

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

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

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Disposable Prophy Angle

Integral Dental Units

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

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

Dental Implant Unit

AllTest Viral Transport Medium

UASure II Blood Uric Acid Monitoring System

Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

ChecQ (AC100)

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

Synea Fusion Handpieces (Intensiv & Profin)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

BDC Dental Unit

VMAT PRO

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

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

Firstar Dental Unit

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

Bowhead ERA Wheelchairs

Safecare Urinary Tract Infection Test

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

HPR Cordless Hygiene Handpiece

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Manual Wheelchair (MASY23)

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)

Nitrile Powder Free Examination Gloves Biodegradable (Green)

Manual Wheelchair (SYIV100-CA9221)

IDS-iSYS Free Testosterone

Digital Prism Correction Feature (DPCF)