10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
FDA 510(k)
FDA Class 1
·General Hospital
Stainless Steel
FDA UDI
Seaspine Orthopedics Corporation·10889981028541·Adjustable Cross Connector, 39mm-42mm. The Stai...
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
FDA 510(k)
FDA Class 1
·Microbiology
AV PLUS DX BIFURCATED BIPOLAR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·August 18, 2011
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 3, 2013
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026