17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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5TH METATARSAL FRACTURE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531361·
ANEURYSM CLIPS
FDA 510(k)
FDA Class 2
·Neurology
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
BD PHOENIX¿ NID
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·March 2, 2022
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 19, 2018
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 11, 2013
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM TITANIUM LIGATING C
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDO·May 19, 2008
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 28, 2019
BD PHOENIX NID
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·July 6, 2021
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·January 31, 2018
AQUAPAK 640 SW, 650ML W/040 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
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