13 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
FDA 510(k)
FDA Class 2
·Neurology
MPS 3 Additive Delivery Line
FDA UDI
QUEST MEDICAL INC·00634624531079·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844887·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE MEDIUM...
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
FDA 510(k)
FDA Class 2
·Orthopedic
PORTEX® ULTRAPERC® SINGLE DILATOR TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
G2 FILTER SYSTEM FEMORAL
FDA Adverse Event
Death
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 28, 2008
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 1, 2022
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024