20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE SURGICAL MASK (MODIFIED)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND EX 14 GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
R120 HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·January 22, 2013
WHITESTAR SIGNATURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS (AMO)·Product code HQC·December 9, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 14, 2014
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DWF·December 15, 2016
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019