11 results · 21ms · Sources: EU EUDAMED, 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