19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESORBABLE LACTOSORB-L ACL CROSSPIN
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H69810143051·Surgical Paper Tape
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810143051·Surgical Paper Tape
N/A
FDA UDI
GEORGE TIEMANN & CO.·B582801430500·CURETTE
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033578407·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033578421·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033578414·
WEISS RETINAL CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZPower Rechargeable System for Hearing Aids
FDA UDI
ZPOWER, LLC·00811204030140·Contains Charger (00811204030195) and two batte...
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·March 10, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·March 13, 2008
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 17, 2015
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 17, 2015
Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Basic Tray with Safety Components, 11G x 4 inch Bone Marrow needle only Product Number: SCE4511
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code FMI·October 8, 2004
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022