17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772826353·LUMBAMED SACRO, GREY, IV
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007498·Mesh Fast Flap Plate Organizer (II)
TISSUE FORCEPS EYE FORCEP MICRO B/H-3 1/2"-SERR .8MM
FDA UDI
W.H. Holden, Inc.·D9282202040·
TISSUE FORCEPS EYE FORCEP MICRO B/H 3 1/2"1X2 STD .8mm
FDA UDI
W.H. Holden, Inc.·D92822020410·
TISSUE FORCEPS EYE FORCEP MICRO B/H 3 1/2"1X2FINE.5mm
FDA UDI
W.H. Holden, Inc.·D92822020430·
TISSUE FORCEPS EYE FORCEP MICRO B/H 3 1/2"SERR STD.5m
FDA UDI
W.H. Holden, Inc.·D92822020420·
ESTEEM
FDA Adverse Event
Malfunction
·ENVOY MEDICAL CORPORATION·Product code OAF·March 9, 2022
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 20, 2025
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
ELECTROSURGICAL GENERATOR
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·February 13, 2024
Surpria 64: Software Version V3.11, V3.22
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021