10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION
FDA 510(k)
FDA Class 2
·Orthopedic
Sterngold Implant System Bone Mill Guide Pin - TRU RP
FDA UDI
STERNGOLD DENTAL LLC·00841549119040·Used to remove an area of crestal bone around t...
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FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978081151·INSTRUMENT 905-810 MESH HOLDER STRAIGHT
STERILE I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 29, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
HAVAB-M
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code LOL·November 23, 2010
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 3, 2015
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013