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

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COOPERSURGICAL TRIAL TRANSFER CATHETER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SHARGHP A.V. FISTULA NEEDLE SET

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

VERSALINK TITANIUM ROD-TO-ROD COUPLERS

FDA 510(k)
FDA Class 2 ·Orthopedic

PROFILE BIABUT 4.0 -Ø5.5

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026

RELIANT DISPOSABLE PENCIL

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code GEI·February 26, 2013

ASR ACETABULAR IMPLANT 54

FDA Adverse Event
Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011

PERIPHERAL CUTTING BALLOON

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION LETTERKENNY·Product code LIT·April 2, 2008

Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

FDA Enforcement
Class II ·Terminated·Childrens Medical Ventures·June 25, 2014

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012