23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OTIS-C PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
Unity Total Knee System
FDA UDI
CORIN LTD·05056139249204·UNITY KNEE™ PS-C INSERT - Size 8 x 18mm
Bernafon
FDA UDI
Bernafon AG·05711584021897·MD3 N, PS SF DB MONDO 3
WeightRight®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020470·Tungsten-Filled Maloney Esophageal Dilator, 18 ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720370·Graefe Eye Dressing Forceps 2-3/4" (7cm), curve...
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
FDA 510(k)
FDA Class 1
·General Hospital
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
HF-RESECTION ELECTRODE, FOR TURIS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 9, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 20, 2013
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·July 28, 2014
COULTER ® LH750
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·June 11, 2011
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 28, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·December 28, 2022
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 27, 2023
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
UNKNOWN CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2018
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 21, 2023