13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEMETECH NYLON NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AOS CANCELLOUS LOCKING SCREW 4.0mm x 28mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008524·
EndoVive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00813939020076·
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·March 27, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
SYNTEL SILICONE THROMBECTOMY CATHETER
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code DXE·April 8, 2024
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 11, 2020
VNGD SSK INTLK FMRL 65 LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018