12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MINI LAP RETRACTORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450494318·
EECP THERAPY SYSTEM, MODEL TS3
FDA Adverse Event
Injury
·VASOMEDICAL, INC.·Product code DRN·December 30, 2002
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 26, 2013
HI-TORQUE PROGRESS 80 GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·September 16, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011
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