18 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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INTRA LUX HEAD 3 LDSY
FDA 510(k)
FDA Class 1
·Dental
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
FDA 510(k)
FDA Class 2
·Radiology
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
V40 COCR LFIT HEAD 40MM/+4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·May 3, 2013
UNKNOWN DEPUY PINNACLE ACETULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·September 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 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
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 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