11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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E-VAC BLOOD CULTURE SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Bardia® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741018329·Bardia® Urethral Catheter - Red Rubber
KETAC-CEM IN REF. TO K802048
FDA 510(k)
FDA Class 2
·Dental
LEDEX, MODEL: WL-070
FDA 510(k)
FDA Class 2
·Dental
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
ESPRIT
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·October 19, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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