19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827851·***DISC*LEVAMED ANKLE SUPPORT BLACK III
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482038697·Symmetry® Probe, Double-Ended, Stainless Steel,...
Phonak
FDA UDI
Phonak AG·07612847817517·Phonak Ambra microM (pure transparent)
CARDIAC VIEW, MODEL 2001
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962108727·PROBE, 5 1/8", DOUBLE ENDED, SS
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·May 2, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 15, 2014
THERMATRX OFFICE THERMO THERAPY SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MEQ·April 19, 2011
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024