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

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SA-3000P

FDA 510(k)
FDA Class 2 ·Cardiovascular

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205

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

TCI-31 LIFELONG OVULATION TESTER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAVEWRITER ALPHA PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2024

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

D903 DIDECO AVANT 2 VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014

IT PADOVA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013

D903 DIDECO AVANT VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013

ADAPTA

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 23, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 1, 2011

INTEGRITY SR

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

C20441 IL HAIFA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

MESH - COMPOSIX KUGEL

FDA Adverse Event
Injury ·DAVOL INC.·Product code FTL·June 14, 2011

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024