57 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
SOMATOM Force, System x-ray, tomography, computed
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code KPR·February 14, 2008
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
FDA Recall
Terminated
·LMA North America Inc·Product code BTR·May 23, 2012
LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202
FDA Recall
Terminated
·LMA North America Inc·Product code CAE·June 18, 2003
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·September 15, 2014
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·September 15, 2014
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
FDA Enforcement
Class II
·Terminated·LMA North America Inc·July 25, 2012
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA Recall
Terminated
·GE Healthcare·Product code IZL·December 19, 2014
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
FDA Recall
Terminated
·GE Healthcare·Product code IZL·December 19, 2014
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
FDA Recall
Terminated
·GE Healthcare·Product code IZL·December 19, 2014