19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
FDA Recall
Terminated
·Omnyx Llc·Product code OTU·October 1, 2013
Bloom DTU-215-B Programmable Stimulator
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JOQ·January 13, 2005
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT-U
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT-U
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA Recall
Open, Classified
·Healthmark Industries Co., Inc.·Product code OCU·March 12, 2026
Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Esaote brand Formul@ ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand ArchiWin Colour ECG System; part 9704325000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Archimed 4220 ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Formula for Archimed ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003