13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AAP ACROPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Graves Wide Angled Medium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030909·Graves Wide Angled Medium 45° 1 3/8" x 4" (35mm...
FX V135 Shoulder Prosthesis
FDA UDI
FX SOLUTIONS·03701037315415·FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V ...
PROACT 1
FDA 510(k)
FDA Class 2
·Physical Medicine
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 28, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 4, 2011
GE 7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·May 29, 2024
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 23, 2024
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 12, 2024
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