21 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Recall
Terminated
·Product code GKR·February 8, 2018
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
FDA Recall
Terminated
·Mizuho America, Inc.·Product code HCH·October 10, 2013
Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
FDA Recall
Terminated
·Mizuho America, Inc.·Product code HCH·October 10, 2013
Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code GKF·May 24, 2005
Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JBF·May 19, 2015
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
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
FDA Recall
Terminated
·Cardinal Health·Product code LRO·October 3, 2005
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