30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVOLUTION MP TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
B.BRAUN
FDA UDI
B.Braun Avitum AG·04039239040743·ABPM Cuff (large) (7102380)
Synergy
FDA UDI
Rmo, Inc.·00885797100993·ROTH SY 018 HK MAX/3 5-5 20 EA
System Drape
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436120866·Non-sterile (76x76cm) polyethlene drape
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800113904927·VICEROY Rod - 5.5 (D)5.5x(L)380mm
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
FDA 510(k)
FDA Class 2
·Neurology
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·March 11, 2020
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 9, 2013
PLUM XLD 110V L.A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 27, 2014
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 20, 2011
MICRUSFRAME10 5MM X 17CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 2.5MM X 3.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
MICRUSFRAME10 6MM X 11.9CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022