14 results · 23ms · Sources: EU EUDAMED, US FDA

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POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE

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

STb Copper Ni-Ti

FDA UDI
ORMCO CORPORATION·00889989025019·STb STRAIGHTWIRE CUNITI 18 x 18 SM PK10

ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT

FDA 510(k)
FDA Class 2 ·Orthopedic

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019

SUMMIT DUOFIX TAP SZ7 STD OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS·Product code LPH·April 9, 2013

VOYAGER NC CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code LOX·April 6, 2011

EASYTRAK 3

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008

StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

FDA Enforcement
Class II ·Terminated·Abbott Vascular·February 22, 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