6,321 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517596666·CoRoent Large MP Ti, 11x9x28mm 0°
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014004·Zirlux 16+ A3 98.5X20
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·March 8, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 22, 2025
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 19, 2019
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 7, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 11, 2022
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 20, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 25, 2026
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 28, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 7, 2026