17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RED DCI-DC3 SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 15, 2015
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·February 17, 2017
COSEAL SURGICAL SEALANT
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code NBE·May 3, 2013
TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30
FDA Adverse Event
Malfunction
·TELEFLEX·Product code GBZ·August 19, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
HAHN TAPERED IMPLANT 4.3 X 11.5 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 30, 2021
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 22, 2021
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021
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