17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QBit Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
HHM
FDA UDI
Oticon A/S·05707131282255·H160V2 TI, BTE 13 WL 85 TC HHM
Biomet® Patellar System
FDA UDI
Biomet Orthopedics, LLC·00887868344404·
BIOMET PATELLAR SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304207974·
PEEK CAS
FDA 510(k)
FDA Class 2
·Orthopedic
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
FDA 510(k)
FDA Class 2
·Ophthalmic
GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·June 6, 2013
HIP HEAD,10/12 TAPER,28MM,+0MM
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 29, 2011
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019
AMISTEM H, HA COATED STEM SIZE 6 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2016
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015