11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-D FILTER NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776103286·Micro Kerrison, 40 Degree Down,
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776103293·Micro Kerrison, 40 Degree Down,
Symmetry HARDY™
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030684·Symmetry® Punch; Hardy Sella; Down 40°; 7 in; 1...
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
EUDERMIC PF POWDER-FREE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 8, 2014
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, LFR·Product code LFR·September 21, 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