18 results · 21ms · Sources: EU EUDAMED, US FDA

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GD Disposable Medical Face Mask

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

CODMAN

FDA UDI
Cerenovus, Inc.·10886704001799·CODMAN SLIM-LINE Aneurysm Clip 90 DEGREES Angle...

7450 RV2 MASK

FDA UDI
HANS RUDOLPH, INC.·00874750005178·ADULT X-SM 7450 MASK/HG/TRPLV

AXS

FDA UDI
Stryker Leibinger GmbH & Co. KG·37613327540605·BONE SCREWS, AXS, SELF-TAPPING

Symmetry Cushing

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482057636·Symmetry® Retractor, Cushing Vein, 18.0 mm, 8 in

BD POSIFLUSH¿ SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 2, 2019

MILLENNIA ACUPUNCTURE NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY

FDA 510(k)
FDA Class 2 ·Dental

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·October 27, 2014

ENTERRA

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 5, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

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

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022

Philips Zenition 70, Model Number: 718133

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024