15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ECAT EXACT HR MODEL 961
FDA 510(k)
FDA Class 2
·Radiology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110966·STERILIZING CASE 4-KNIVES
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm
BREAST BOLSTER
FDA 510(k)
FDA Class 2
·Radiology
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
FDA 510(k)
FDA Class 2
·Cardiovascular
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 13, 2010
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
NONE
FDA Adverse Event
Malfunction
·Product code BZA·December 14, 2012
REGEN/RNGLC+ LTD 48MM SZ 22
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 26, 2017
RINGLOC TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 26, 2017
CER BIOLOXD MOD HD 32MM -3NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·October 26, 2017
E-POLY 32MM +3 MAXROM LNR SZ22
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MAY·October 26, 2017
G7 APICAL HOLE PLUG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·October 26, 2017
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021