12 results
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24ms
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Sources: EU EUDAMED, US FDA
ALLERGAN HUMPHREY A/B SCAN , MODEL 835
FDA 510(k)
FDA Class 2
·Radiology
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304464186·
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
5.0MM TI W/ MAXBRAID NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 9, 2014
UNIFY QUADRA, CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 12, 2010
5.0MM TI W/ MAXBRAID NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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