11 results · 30ms · Sources: EU EUDAMED, US FDA

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LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)

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

Screw Holding Forceps - Long (SG 1109)

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215083441·

BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·January 28, 2020

AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm

FDA 510(k)
FDA Class 2 ·Cardiovascular

EZ-JECT

FDA 510(k)
FDA Class 2 ·General Hospital

E SERIES DEFIBRILLATOR

FDA Adverse Event
Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 2, 2008

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 10, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·February 13, 2020

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024