68 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·September 29, 2012
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·September 25, 2012
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·September 25, 2012
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code KTT·October 25, 2012
IMPAX CV Results Manager/Results Manager Administration Tool
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·June 11, 2010
ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·April 25, 2012
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJL·October 25, 2012
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·October 25, 2012
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·October 30, 2012
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
FDA Recall
Terminated
·Oscor, Inc.·Product code LDF·July 25, 2012
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·June 25, 2012
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·June 26, 2012
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·September 24, 2012
Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·September 24, 2012
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·September 24, 2012
Philips Digital Diagnost Stationary radiographic system
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·October 30, 2012