28 results
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20ms
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Sources: EU EUDAMED, US FDA
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
FDA 510(k)
FDA Class 2
·Anesthesiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776180201·Cushing Tissue Forceps Str Teeth
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925016583·GOLDMAN CVD PICK SHARP.1 1.2 RAD
ArgenZ HT+ 98x25 ML OM2B
FDA UDI
ARGEN CORPORATION, THE·D818130405·Dental porcelain/ceramic restoration kit
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378594·Integra® Jarit® Cushing Tissue Forceps, 6-3/4",...
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585075·Apex Tibial Nail Ø 13 x 405mm
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506082252·Cushing tissue forceps, straight, 1x2 teeth, sc...
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VALUEBLUE PENCIL, RS VB STERILE
FDA Adverse Event
Malfunction
·ZHEJIANG SHUYOU SURGICAL·Product code GEI·February 1, 2023
HIGH FLOW TRAUMA TIP WITH SOFT CONE SPLASH SHIELD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-PUERTO RICO·Product code FQH·May 24, 2013
ELECTRONIC FOOT CONTROL W/DIR ONLY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 30, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 24, 2014
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 19, 2015
BACT/ALERT MP - 419744
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 5, 2019
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 96-2740.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005