10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962159040·OPERATING SHEATH, 2 STOPCOCKS, ROTATABLE, DIA2M...
OPTIMUM WETTING AND REWETTING DROP
FDA 510(k)
FDA Class 2
·Ophthalmic
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 8, 2013
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·November 3, 2010
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019