12 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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GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
FDA 510(k)
FDA Class 2
·Radiology
CONMED
FDA UDI
Conmed Corporation·10845854033449·MICRO TAPERED FISSURE BUR, LONG, 1.2 X 2.3 MM, ...
2.4MM CORTEX SCREW, SELF-TAPPING
FDA 510(k)
FDA Class 2
·Orthopedic
ACUTEVENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 23, 2018
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 3, 2013
ARTICUL/EZE ZIR BALL 28 +8.5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·September 16, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011
NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 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