11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATHFORMER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809846362·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE LARGE FU...
INFINITY MICRO2+
FDA 510(k)
FDA Class 2
·Cardiovascular
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
FDA 510(k)
FDA Class 2
·General Hospital
BD SYRINGE 1ML LS 25G 5/8IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 13, 2024
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 15, 2011
POSTERIOR CHAMBER INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQL·May 23, 2008
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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