16 results · 21ms · Sources: EU EUDAMED, US FDA

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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