452 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TECNIS ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·March 7, 2019
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
FDA Recall
Terminated
·Perkinelmer·Product code JNB·November 26, 2012
Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code JNB·January 26, 2010
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
FDA classification
FDA Class 2
·Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
JSB DENTAL, INC.
FDA registration
JSB DENTAL, INC.·2 products·🇺🇸 United States
JEB TECHNOLOGIES LIMITED
FDA registration
JEB TECHNOLOGIES LIMITED·3 products·🇬🇧 United Kingdom
JNH INTERNATIONAL INC
FDA registration
JNH INTERNATIONAL INC·1 product·🇺🇸 United States
PORTA
FDA UDI
JOB CORPORATION·04582373840071·Mobile X-ray system
AN-B
FDA UDI
AGNES MEDICAL CO., LTD.·08800067700460·Single Use RF Electrode
TI-6AL-7NB URTN
FDA 510(k)
FDA Class 2
·Orthopedic
Versus Catheter (VS110-9NB)
FDA 510(k)
FDA Class 2
·Cardiovascular
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030377·Plate, Static Aileron, No Bullet, 6mm
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030735·AILERON Static Posterior Fusion Plate, 18mm Slo...
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030674·Plate, Static Aileron, No Bullet, 16mm
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664882897·One piece ECG Monitor Cable/Marquette/3-lead/gr...
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030360·Core, Static Aileron, No Bullet, 6mm
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823102935·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030544·Core, Static Aileron, No Bullet, 12mm
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030605·Core, Static Aileron, No Bullet, 14mm
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030667·Core, Static Aileron, No Bullet, 16mm