9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NA NEEDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORA Implant Abutment 3.0mm Cuff (BH)
FDA UDI
STERNGOLD DENTAL LLC·00841549112898·The ORA System is indicated for use with dental...
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LATEX CONDOMS - CODE NO. 401, 421 & 1002
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021
CAPTURA SERRATED FORCEPS W/O SPIKE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code FCL·May 23, 2014
LOW PROFILE SELF TAPPING BONE SCREW 6.5MM X 25MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 22, 2010
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024