16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LEGION Inserts with JRNY Lock
FDA 510(k)
FDA Class 2
·Orthopedic
CHADWICK SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054981·CHADWICK SCISSORS CURVED SHARP BLADES POWER CUT...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032681·FPS .157 x 9" Fully Threaded Steinman Pin
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856001947·CP Ti PRECONTOURED ROD 5.5 DIA X 70mm
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930324·BIT, TREPHINE 6.0MM AO
OsteoMed
FDA UDI
OSTEOMED LLC·00845694073042·FPS .157 x 9" Fully Threaded Steinman Pin Steri...
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LORENZ BLUE DEVICE
FDA 510(k)
FDA Class 2
·Dental
ZODIAC PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE INC.·Product code KWP·May 10, 2007
SAVANNAH
FDA Adverse Event
Malfunction
·SPINAL ELEMENTS, INC·Product code NKB·September 29, 2022
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013
SPIRALOK 5.0MM O-C NO NEEDLES
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·February 12, 2020
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014