18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Alphenix, INFX-8000C/B, V8.0
FDA 510(k)
FDA Class 2
·Radiology
X-CORE
FDA UDI
Nuvasive, Inc.·00887517103673·X-CORE 2 Ti Endcap, 18mm Rnd 4° Ø16
X-CORE
FDA UDI
Nuvasive, Inc.·00887517293961·X-CORE 2 Ti Endcap, 18mm Rnd 4° Ø18
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902525308·INSTRUMENT 9181804 4 IN 1 KEEL CHSL TIP
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512861·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111818040·Coxa Vara Collared Stem, Size 18
PIONEER PLUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GIRAFFE AND PANDA WARMERS
FDA 510(k)
FDA Class 2
·General Hospital
311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP
FDA Adverse Event
Injury
·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022
6000CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Injury
·ETHICON·Product code GAN·July 27, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 18, 2008
1823260-2015-04525
FDA Adverse Event
Malfunction
·November 12, 2015
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023