14 results
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28ms
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Sources: EU EUDAMED, US FDA
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