15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUCTION COAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLY STAT HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EL-ANA PROFILES-2K1
FDA 510(k)
FDA Class 2
·Immunology
LINEAR? 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 6, 2025
DEKA SMARTXIDE WITH DOT SCANNER
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 14, 2023
IMP,TSV,4.1MM,SBM,13
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 23, 2013
ARIA RADIATION ONCOLOGY
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·April 20, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
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
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 Enforcement
Class II
·Terminated·Cure Medical LLC·October 10, 2012
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012