14 results · 28ms · Sources: EU EUDAMED, US FDA

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ANSPACH INSTRUMENT CADDY

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Nupro® Prophy Paste with Fluoride

FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013291·Nupro® Prophy Paste with Fluoride - Chocolate B...

Symmetry Hardy

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030561·Symmetry® Enucleator, Hardy, Reverse Curve, 9.2...

ACUMED

FDA UDI
Acumed LLC·10806378048449·Pelvic Plating Screw/Plate Inst. Platter

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450179536·

INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 8, 2014

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·October 23, 2012

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 28, 2015

SMR REVERSE HUMERAL BODY SHORT

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code KWS·May 27, 2019

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

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025