18 results · 22ms · Sources: EU EUDAMED, US FDA

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TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT

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

BILOX PROSTHESIS HEAD 12/14 28MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANCURE LLIAC BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM M

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 32MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

GLOBAL ADVANTAGE ECC HD 44X18

FDA Adverse Event
Injury ·J & J MEDICAL (DEPUY- SUZHOU)LTD. 3006356043·Product code KWS·April 23, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER INC.·Product code MMI·May 2, 2011

RIATA ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Enforcement
Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

UNK

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·October 11, 2010

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

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022