22 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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2MP Monochrome LCD Monitor MS-S200
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628954·CoRoent Ant TLIF Ti, 11x10x34mm 15°
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776407162·3MM, 45CM, PALPATION TACTILE PROBE W/ CM MARKING
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185206·AccuFit™ Molar Band UL7 - 34.5
Radius Plate PROlock II
FDA UDI
I.T.S. GmbH·09120047296936·Radius Plate PROlock II, Wide, 5-Hole, Left
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039440·BRW/CRW-GUIDE BUSHING FOR T-DRIVER, FOR 2.7MM A...
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 13, 2022
HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753
FDA Adverse Event
Malfunction
·JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IOR·December 19, 2014
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
FDA 510(k)
FDA Class 2
·Orthopedic
SCANVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
JUVEDERM ULTRA XC TSK ROW
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·August 9, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C230 (Reorder No. (21-0345-25) for product distributed Internationally. Model Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014