11 results
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35ms
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Sources: EU EUDAMED, US FDA
PHOTOMETER LP 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127610·
Symmetry MICROCARE®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031209·Symmetry® Case, Microcare Instrument, Dimension...
SMARTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
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
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 16, 2007
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·October 23, 2012
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