18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes TFNA Augmentation System
FDA 510(k)
FDA Class 2
·Orthopedic
TFNA FEM NAIL Ø10 R 125° L320 TIMO15
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018
10MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821601670·SCISSORS, SURGICAL TISSUE, DENTAL
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044563·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290211·Denovo general purpose dental molar band - Maxi...
ATRIA 3100, ATRIA 6100
FDA 510(k)
FDA Class 2
·Cardiovascular
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·September 16, 2008
PEDIASAT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 26, 2018
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026