14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Mini Screws
FDA 510(k)
FDA Class 2
·Dental
Lockheed - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021888·OPTYC MBT CEN +17T +4A 022 UL
Symmetry Sauerbruch
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482060131·Symmetry® Retractor, Sauerbruch, 2 1/8 in Deep,...
n/a
FDA UDI
Ortho Development Corporation·00822409068111·Slotted Stem Trial 23x150mm
FOLYSIL CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·July 16, 2020
FOLYSIL CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·July 16, 2020
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEATTLE - PAP
FDA 510(k)
FDA Class 2
·Anesthesiology
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962114179·SAUERBRUCH RETRACTOR, 9", #2, 15/16"X2 1/8" BLADES
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
TREATMENT RECLINER
FDA Adverse Event
Malfunction
·GLOBAL·Product code FRK·July 22, 2011
EONC
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
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