12 results · 20ms · Sources: EU EUDAMED, 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