14 results · 19ms · Sources: EU EUDAMED, US FDA

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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