14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VeriFixx Small Bone Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112625·BARRON CORNEAL PUNCH 7.75MM
VACUETTE WITH PPACK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MANUAL TOUCHE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 2, 2013
WORKING ELEMENT ACTIVE MONO 12/30°
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code FDC·February 22, 2019
HF CONNECTION CABLE MONO
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code GEI·February 22, 2019
HF CONNECTION CABLE MONO
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code GEI·February 22, 2019
WORKING ELEMENT ACTIVE BIPO 0/12/30
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code FDC·February 22, 2019
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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