18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033599·Baltic Denture System BDLoad BDLoad ↓ Mw7 PLSEu...
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 17, 2024
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 17, 2024
SeaSpine
FDA UDI
Avalign Technologies, Inc.·00190776149505·ANGULAR TEMPLATE, 35degrees
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776391386·Angular Template, 35
IMMUNOCARD STAT! E. COLI O157 PLUS
FDA 510(k)
FDA Class 1
·Microbiology
SMITH & NEPHEW SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
PN 32G X 4MM BENELUX
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·March 5, 2024
ACT ARTIC E1 HIP BRG 28X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 6, 2017
G7 DUAL MOBILITY LINER 42MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·December 6, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 30, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·April 24, 2008
LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE OBLIQUE LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 12, 2019
LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE OBLIQUE LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 12, 2019
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024