9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriMAX Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741948·Spratt (Brun) Bone Curette 9" (22.5cm), straigh...
TELAVANCIN 30 UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 21, 2014
PLUM XLMD PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 6, 2008
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 26, 2013
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
FDA Enforcement
Class III
·Terminated·MICROVENTION INC.·June 16, 2021
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014