8,280 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ASTRALIS 7, MODEL 557545
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040028872·Plaster & Stone Remover
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033471012·
AMS FASCIAL-ANCHORING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013
UNK ZIMMER HUMERAL INSTRUMENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWT·March 8, 2011
APR HIP SYSTEM ENHANCED ACETABULAR INSERT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWB·March 14, 2008
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 26, 2024
PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 23, 2022
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