11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BURRON MULTI-AD SYRINGE CAP
FDA 510(k)
FDA Class 2
·General Hospital
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013111·NUPRO® Prophy Paste, Razzberry, Fine, Single Bo...
Symmetry Hardy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030479·Symmetry® Enucleator, Hardy Micro, Left, 9.25 in
SYNTHES (USA) ORIBITAL MESH PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
UNIFY ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 8, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
BD¿ IV SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 22, 2018
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