14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL FACE MASK (Ear Loops and Tie-on)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Forestanit®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21330701·Forestanit wire round spring-hard clinic coil 0...
Portex
FDA UDI
ICU MEDICAL, INC.·15019315020353·
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
FDA 510(k)
FDA Class 2
·Orthopedic
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code BTR·February 7, 2025
PORTEX IVORY NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTR·July 22, 2019
ENDOTRACHEAL TUBES POLAR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD,INC·Product code BTR·February 23, 2020
PORTEX
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·January 7, 2022
FEM-NECKSCR Ø11 SELF-TAP L105 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024