22 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Picosure Workstation
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIXIEEMS
FDA UDI
Wenzhou Caretek Medical Device Co., Ltd.·06975871430338·NURSES STETHOSCOPE RED
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266818·
ORTHODONTIC SCREW
FDA 510(k)
FDA Class 2
·Dental
TEMPUSIC PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BELLATEK® ABUTMENT TSV 3.5MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·February 5, 2021
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·January 20, 2017
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 12, 2014
ABUTMENT, PATIENT SPECIFIC, TITANIUM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 3, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 4, 2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61'', 1.4 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FPA·August 3, 2005
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015