12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025554·Kocher-Langenbeck Retr, 70x14mm, 8 1/2"
LUMINOS AGILE
FDA 510(k)
FDA Class 2
·Radiology
DYNAPBV BODY SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·October 17, 2014
LS LF PP PRIM SYM SET PGB W/BCKCK V 2 CL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 8, 2011
ADM BALL IMPACTOR TIP
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 21, 2013
CHROMID® CARBA SMART
FDA Adverse Event
Malfunction
·BIOMERIEUX S.A.·Product code JSO·August 23, 2018
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021