706 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HRS·September 3, 2021
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 13, 2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·June 9, 2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HXX·April 15, 2021
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code LEJ·July 8, 2005
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code LEJ·July 25, 2014
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code 000·May 7, 2012
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·August 22, 2012
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 19, 2012
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 24, 2014
X-ray, Computed Tomography, Model TSX101A
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code JAK·January 14, 2003
VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
FDA Recall
Terminated
·Product code JDK·September 19, 2007
Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAK·August 1, 2009
Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 2, 2011
Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 18, 2012
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 15, 2013
Xoran Mini CT Scanner
FDA Recall
Terminated
·Xoran Technologies, Inc.·Product code JAK·July 27, 2010
Xoran Minicat00158
FDA Recall
Terminated
·Xoran Technologies, Inc.·Product code JAK·July 27, 2010
Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 2, 2003