18 results · 22ms · Sources: EU EUDAMED, US FDA

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Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MONOBLOC REAMER 10.5mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000832·

Curette

FDA UDI
KATENA PRODUCTS, INC.·00841668102121·SCORSETTI-SHEPHERD POLISHER

Sklar®

FDA UDI
SKLAR CORPORATION·10649111139826·SKLARLITE OP SCISS SB ST 5

Epilaser Absolute

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ear-Friendly Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

FRESENIUS

FDA Adverse Event
Injury ·FMC·Product code FJK·February 17, 2000

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 7, 2024

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 7, 2024

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 7, 2024

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 26, 2011

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 21, 2008

PLUM XLM W/DATAPORT

FDA Adverse Event
Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013

The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

BD CONVENTIONAL NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·February 20, 2024

SYNERGY VERSITREL

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 11, 2015

BD CONVENTIONAL NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·February 23, 2024

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021