8 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SAMPLES TRANSPORT, BOXES

Device
EU IVDR · Eu Ivd Class A ·2cureX A/S·On the market·32 countries

Calibration plate. Box of 10

Device
EU IVDR · Eu Ivd Class A ·RefLab Aps·On the market

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Preparation Vial (IL-3), Box of 5

Device
EU IVDR · Eu Ivd Class A ·RefLab Aps·On the market

VariSoft Infusion Set, Single Use.

FDA Enforcement
Class II ·Ongoing·Unomedical A/S·September 25, 2024

ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

FDA Enforcement
Class II ·Terminated·Mermaid Medical A/S·July 29, 2015