88 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOTLINE 2 FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
FDA 510(k)
FDA Class 2
·Anesthesiology
NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE
FDA Adverse Event
Malfunction
·SYNTHES NORIAN·Product code MQV·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 28, 2011
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·July 3, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 15, 2021
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DQX·July 2, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·August 12, 2024
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 25, 2022
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·May 3, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·June 4, 2024
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·September 1, 2022
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 8, 2024
LUNDERQUIST-RING TORQUE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·September 28, 2021
SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 7, 2022
COONS INTERVENTIONAL WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 21, 2022
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·August 22, 2024