13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
SKIN BIOPSY DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURESUBTRACTION LUNG
FDA 510(k)
FDA Class 2
·Radiology
COMPRESSION ANASTOMOSIS CLIP (CAC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONVERTBL I.V.DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011
CONVERTBL I.V..DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 13, 2009
PRIMARY PLUMSET PP YSITE 272CM NDEHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012
CONVERTBL I.V. DUAL C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
CONVERTBL I.V. DUAL CHANNEL HSP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·December 2, 2010
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 29, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019