22 results · 24ms · Sources: EU EUDAMED, US FDA

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METOXIT CAM-BLANKS

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO: INJECTABLE MIMIX

FDA 510(k)
FDA Class 2 ·Neurology

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

FDA 510(k)
FDA Class 2 ·General Hospital

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 29, 2021

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

IMP,TSV,4.1MM,SBM,13

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025

E.CAM

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

SYMBIA T-SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

TERUMO TCM II COOLING AND HEATING SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·April 18, 2013

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·April 21, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

E.CAM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 21, 2025

IMP,TSV,4.1MM,SBM,11.5

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 18, 2024

IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 1, 2023

Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

FDA Recall
Terminated ·Cure Medical LLC·Product code EZD·September 19, 2012