10 results
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36ms
·
Sources: EU EUDAMED, US FDA
Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TEMPUS IC PROFESSIONAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
FDA 510(k)
FDA Class 2
·Microbiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 2, 2016
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 26, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018