11 results · 20ms · Sources: EU EUDAMED, US FDA

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ACE FISCHER EXTERNAL FIXATION DEVICE

FDA 510(k)
FDA Class 1 ·Orthopedic

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127757·

MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE

FDA 510(k)
FDA Class 1 ·General Hospital

3.5 MM LAPAROSCOPE (LG100, LG103)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

MICRUSPHERE 18 - CERECYTE MICROCOIL

FDA Adverse Event
Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·October 23, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 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

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025