17 results · 20ms · Sources: EU EUDAMED, 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