11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEWPORT HT70 FAMILY OF VENTILATORS
FDA 510(k)
FDA Class 2
·Anesthesiology
TRACH T WITH ONE-WAY VALVES
FDA 510(k)
FDA Class 1
·Anesthesiology
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
AZO
FDA Adverse Event
Other
·SIEMENS DIAGNOSTICS, INC.·Product code CEN·July 12, 2012
HOLD-SL F/SPIRIT SLOTTED SHORT F/CLICKX
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·March 6, 2013
TRABECULAR METAL SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 8, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026