19 results · 20ms · Sources: EU EUDAMED, US FDA

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CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUSTOM PROCEDURE KIT

FDA UDI
MEDIVATORS INC.·40677964006805·The ENDO CARRY-ON Procedure Kit contains all of...

MediClear™ PreOp

FDA UDI
Covalon Technologies Ltd·00825439016169·Antimicrobial Self-Adherent Silicone Film Drape...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092165744·NobelActive™/Conical-compatible NP Engaging Ver...

Thermoflect

FDA UDI
Encompass Group, L.L.C.·00612899004290·THERMOFLECT GOWN KIT D, 25 EA ...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092126165·NobelActive™/Conical-compatible NP Engaging Ver...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327505238·Standard Tracker and Pointer Insert Tray

HARDYDISK, NALIDIXIC ACID, 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CARDIOSAVE HYBRID W/ E/F PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 24, 2025

UNK XEN STENT

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·July 22, 2022

QUALITY ELECTRODYNAMICS

FDA Adverse Event
Malfunction ·QUALITY ELECTRODYNAMICS, LLC·Product code MOS·August 30, 2019

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011

EMBRACE PUMP

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018