271 results · 24ms · Sources: EU EUDAMED, US FDA

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On Site Gas Systems POGS 33C Portable Oxygen Generation System

FDA Recall
Terminated ·On Site Gas Systems Inc.·Product code CAW·December 19, 2013

On Site Gas Systems POGS 33C Portable Oxygen Generation System

FDA Enforcement
Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

FDA Enforcement
Class II ·Terminated·Covidien LP·June 27, 2012

Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

FDA Enforcement
Class II ·Terminated·Covidien LP·June 27, 2012

Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

FDA Enforcement
Class II ·Terminated·Covidien LP·June 27, 2012

Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

FDA Enforcement
Class II ·Terminated·Covidien LP·June 27, 2012

Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

FDA Enforcement
Class II ·Terminated·Covidien LP·June 27, 2012

Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107

FDA Recall
Terminated ·Pride Mobility Products Corp·Product code ITI·April 11, 2008

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

TopCare Clifford THE BIG RED DOG power toothbrush for kids!

FDA Recall
Terminated ·Ranir Corporation·Product code JEQ·December 18, 2013

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

FDA Enforcement
Class II ·Terminated·POM Medical LLC·November 6, 2019

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium

FDA Enforcement
Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium

FDA Enforcement
Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

TopCare Clifford THE BIG RED DOG power toothbrush for kids!

FDA Enforcement
Class II ·Terminated·Ranir Corporation·January 29, 2014

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

FDA Enforcement
Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium

FDA Enforcement
Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

FDA Enforcement
Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium

FDA Recall
Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

FDA Recall
Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium

FDA Recall
Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018