27 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

Premier K-FILES

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053293·FILES PKG 6 31MM 15

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496053293·NIGHT WELLNESS 70, SIZE S, ROSA, GRADUATED COMP...

EXCITE DSC

FDA 510(k)
FDA Class 2 ·Dental

NIPRO HYPODERMIC NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 20, 2016

VG DA 360 O/S TIB TRAY COCR 63

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2016

VG DA360 TIB BRG ARCM 71/75X24

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016

5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 79/83 X 14MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·December 6, 2016

VG DA 360 O/S TIB TRAY COCR 71

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 1, 2016

BALLOON

FDA Adverse Event
Injury ·EXTERNAL MANUFACTURER·Product code DYB·April 11, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

FOUNDATION KNEE SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSH·May 28, 2008

VG DA 360 O/S TIB TRAY COCR 67

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·August 3, 2018

VANGUARD DA360 TIBIAL BEARING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 14, 2017

VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·February 6, 2017

VG DA 360 TIB BRG ARCM 79/83X14

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 19, 2016

VANGUARD DA360 TIBIAL BEARING 63/67X18

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016