10 results
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35ms
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Sources: EU EUDAMED, US FDA
DODICK LENS HOLDING FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
FDA 510(k)
FDA Class 2
·Cardiovascular
DA VINCHI EMG/EP ISA1004EP
FDA 510(k)
FDA Class 2
·Neurology
ALUMINUM SPOON RETRACTOR MEDIUM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GAD·December 7, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
CBCII BLOOD CONSERVATION RESERVOIR ONLY
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·October 11, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 9, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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