13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450494318·
TRIDENT ACETABULAR SHELLS: PS
FDA 510(k)
FDA Class 2
·Orthopedic
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CADD EXTENSION SET TUBING
FDA Adverse Event
Malfunction
·Product code FPA·October 18, 2021
PASSPORT V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·April 30, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014
CBCII(NO DRN)PKG/6 W/CAPACITOR
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·May 4, 2011
PROXIMAL HUMERUS, LEFT, ÿ 11X160MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·March 18, 2024
BLUNT TIP SCREW, ÿ 4X36MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·March 18, 2024
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code OOI·July 11, 2012
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012