19 results · 21ms · Sources: EU EUDAMED, 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