11 results
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21ms
·
Sources: EU EUDAMED, US FDA
FMS-02 FLOOR-UNIT MODEL MICROSCOPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828027130·AWL
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580271300001·SURE-SNAP 2. MOLAR UPR LFT SZ 13
TrueView 100 Pro
FDA 510(k)
FDA Class 2
·Radiology
TIGER FLAT SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2014
SWEET TIP
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVN·October 24, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024