10 results
·
30ms
·
Sources: EU EUDAMED, US FDA
IMMUNOCARD STAT! FLU A & B
FDA 510(k)
FDA Class 2
·Microbiology
HALLU PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
CONCORD 72
FDA 510(k)
FDA Class 2
·Dental
SERIES 7000 STANDARD TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·June 30, 2010
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 22, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, CORP·Product code HWC·June 22, 2018
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·April 8, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 24, 2011
SELUTE PICOTIP LEAD
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 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