14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPRASORB A +AG
FDA 510(k)
FDA Unclassified
·Unknown
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small
Sklar®
FDA UDI
SKLAR CORPORATION·10649111128981·F.O. MAC ENG STYLE SZ2 4.5MM
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2017
ESU HANDSWITCHING PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
FDA 510(k)
FDA Class 2
·General Hospital
PLUM A+ - ANIMAL HEA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·October 4, 2024
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 14, 2014
5.5MM TAP (CANNULATED)
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 22, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWP·April 28, 2011
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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