10 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694994·Fixation Pin Sleeve
StrykeFlow
FDA UDI
STRYKER CORPORATION·07613327051766·Reusable Suction Irrigation Tip, Hydrodissectio...
LORENZ BLUE DEVICE
FDA 510(k)
FDA Class 2
·Dental
ADVISOR, MODEL 9200
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 3, 2020
ENDOVIVE® SAFETY PEG KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 22, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 19, 2011
RX DILATATION BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORK LTD.·Product code KOG·July 3, 2008
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·May 15, 2013