12 results · 19ms · Sources: EU EUDAMED, US FDA

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PULPDENT DIAMOND POLISH

FDA 510(k)
FDA Class 1 ·Dental

FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM

FDA 510(k)
FDA Class 2 ·Cardiovascular

THIN FILM DRESSING FOR ULTRASOUND EXAM

FDA 510(k)
FDA Class 2 ·Radiology

COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JDI·December 15, 2016

COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016

BIOMET COBALT-CHROME FEMORAL COMPONENTS

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDI·March 17, 2017

COBALT CHROME FEMORAL HEAD

FDA Adverse Event
Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017

SYSTEM 7 RECIP SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·January 11, 2013

SOVEREIGN COMPACT

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS (AMO)·Product code HQC·November 22, 2010

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 2, 2014

BIOMET COBALT-CHROME FEMORAL COMPONENTS

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017

The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

FDA Recall
Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009