12 results · 20ms · Sources: EU EUDAMED, US FDA

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FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

DELFIA NEONATAL IRT KIT, MODEL A005-110

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COALESCENT SURGICAL U-CLIP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GRAFTYS BCP (510K NUMBER: K073064)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

PROLENE POLYPROPYLENE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·April 23, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011

INVACARE LIFTS AND SLINGS

FDA Adverse Event
Injury ·INVACARE CORPORATION - MANUFACTURING FACILITY·Product code FSA·July 9, 2008

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

DIMENSION EXL 200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013

UNKNOWN PFM-R DISTAL STEM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015