15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lubrigyn cream
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HHM
FDA UDI
Oticon A/S·05707131284907·H160V2, RITE 312 WL CNB HHM
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450136799·
Trial Cage 25deg 19S
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066796·
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 7, 2014
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·May 1, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024