16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIEZOSURGERY 3; OSSTEM PIEZO
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450249765·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450261408·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450252963·
REGAL MOTOTRIZED 3 WHEELED VEHICLE
FDA 510(k)
FDA Class 2
·Physical Medicine
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
FDA 510(k)
FDA Class 2
·Ophthalmic
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 15, 2016
PASSPORT V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
HP MBT CEM KEEL PUNCH SZ 4-7
FDA Adverse Event
Malfunction
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LXH·September 16, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 20, 2011
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·May 7, 2019
NEB100
FDA Adverse Event
Malfunction
·SUNSET HEALTHCARE SOLUTIONS·Product code CAF·January 29, 2019
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 14, 2017
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-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