14 results
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24ms
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Sources: EU EUDAMED, US FDA
SURCAN KNEE HOLDING DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Terumo® Advanced Perfusion System 1
FDA UDI
Terumo Cardiovascular Systems Corporation·00886799000755·The Interface Module for CDI 100 provides the i...
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918147468·Poly bag sub assembly-6EA/CS_N/S
COMFORTLITE NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
FDA 510(k)
FDA Class 2
·Immunology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·October 19, 2012
TRIDENT PSL HA CLUSTER 48MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·August 10, 2010
Terumo Advanced Perfusion System 1 Data Interface CDI 100; Catalog number 802558.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ¿ ROUND LAKE·Product code LHI·January 30, 2019
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 29, 2012
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024