11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARISOURCE BREAST TEMPLATE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)
PERSONAL ECG TRANSMITTER, MODEL CG-6550
FDA 510(k)
FDA Class 2
·Cardiovascular
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
FDA 510(k)
FDA Class 2
·Ophthalmic
SURGIGUIDE - 3 IMPLANTS
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS N.V.·Product code NDP·May 16, 2023
TRILOGY SHELL WITH CLUSTER HOLES
FDA Adverse Event
Malfunction
·ZIMMER·Product code LPH·February 27, 2013
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·February 15, 2011
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 15, 2014
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIU·May 31, 2023
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
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