11 results · 23ms · 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.

FLYNNR GENESIS II A/C, A/O AND IDLH

FDA 510(k)
FDA Class 2 ·Anesthesiology

Reef TH

FDA UDI
Seaspine Orthopedics Corporation·10889981202675·Interbody, 9mm x 32mm x 17mm, 0 deg

Reef TA

FDA UDI
Seaspine Orthopedics Corporation·10889981194680·Interbody, 9mm x 32mm x 17mm, 0 deg

TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000

FDA 510(k)
FDA Class 2 ·Anesthesiology

SHASER V-MINI RX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENDO GIA ADAPTER STANDARD

FDA Adverse Event
Malfunction ·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code GDW·April 3, 2014

UNKNOWN STRATA VALVE/SHUNT

FDA Adverse Event
Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·January 25, 2013

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·December 8, 2010

ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHS·February 1, 2021

ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHS·February 1, 2021

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018