10 results
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19ms
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Sources: EU EUDAMED, US FDA
U.I. OCTOSON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUMED
FDA UDI
Acumed LLC·10806378050923·Ratcheting Compression Plate Tamp
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132461·
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
REAGENTS FOR DETERM. TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
5.5MM X 40MM S-LOK POLYAXIAL SCREW
FDA Adverse Event
Injury
·PRECISION SPINE, INC.·Product code MNI·April 28, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 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