31 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNA LOCKING ANKLE NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235169·SCREW 3120419 4.0 X 19 SELF DRILL FIX
N/A
FDA UDI
Tyber Medical, LLC·M695M1204190·
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
V SET
FDA 510(k)
FDA Class 2
·General Hospital
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
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 10, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 27, 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
ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·July 25, 2012
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 12, 2012
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 27, 2023
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 10, 2013