13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304213814·
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007494·GLOBAL KEELED GLENOID PREMIERON X-LINKED PE 56mm
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
FDA 510(k)
FDA Class 2
·Microbiology
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BALL FLUTED 10BA30
FDA Adverse Event
Other
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBE·December 5, 2006
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 15, 2013
ESSURE
FDA Adverse Event
Malfunction
·BAYER PHARMA AG·Product code HHS·September 24, 2014
AMPHIRION DEEP PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·INVATEC INNOVATIVE TECHNOLOGIES, SPA·Product code DQY·May 17, 2011
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023