30 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
FDA 510(k)
FDA Class 2
·Immunology
Conventional Lead Apron .5mm Small 22 X 33
FDA UDI
Flow X Ray Corporation·00843696123093·Conventional Lead Apron .5mm Small, Black
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482057506·Sterilization Tray 8" X 25 1/4" X 3 1/2"
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365113048·
Zavation
FDA UDI
Zavation LLC·00842166123304·Lateral Offset
microTargeting™ Stylet
FDA UDI
FHC, INC.·00873263008256·microTargeting DP Stylet, nonsterile, for use w...
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KING OF HEARTS EXPRESS + AF MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962112687·STERILIZATION TRAY, 8"X25 1/4"X3 1/2", SS
Widex
FDA UDI
Widex A/S·05706069735628·Widex BEYOND B-F2 (Cappuccino brown S-440 ) Tel...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
FDA Enforcement
Class II
·Terminated·Cardiac Assist, Inc·February 19, 2020
RADIAL JAW 3 BIOPSY FORCEP W/NEEDLE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNW·May 23, 2008
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013
2520274-2014-00896
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·February 26, 2014
2520274-2014-00897
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·February 26, 2014
UNK - CONSTRUCTS: PFNA LONG
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·August 19, 2021
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 27, 2020