17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccuCath Ace Intravascular Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Brasseler USA
FDA UDI
Provision·B504OMKM331060·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113813·VISCO CANNULA 27GA ANGLE 8MM
Brasseler USA
FDA UDI
Provision·00810041064868·
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094180·KM33-106
BLUEENDO
FDA UDI
TROKAMED GmbH·04251303811381·Obturator Ø 15 mm, to be used with 02-33103, Co...
NA
FDA UDI
STERILMED, INC.·10888551017039·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
FDA 510(k)
FDA Class 2
·Microbiology
COMPUTED RADIOGRAPHY SCANNER
FDA 510(k)
FDA Class 2
·Radiology
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 18, 2008
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 22, 2011
S-ROM*SLEEVE PRX ZTT, 18D-LRG
FDA Adverse Event
Malfunction
·DEPUY (IRELAND) - 9616671·Product code LPH·July 18, 2013
VOCSN PATIENT BREATHING PACKAGE
FDA Adverse Event
Malfunction
·VENTEC LIFE SYSTEMS, INC·Product code CBK·September 14, 2024
Allura Xper FD20/15; Catalog numbers: 722058
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025