17 results · 21ms · Sources: EU EUDAMED, US FDA

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VISIOFOCUS

FDA 510(k)
FDA Class 2 ·General Hospital

Medline Industries, Inc.

FDA UDI
MEDLINE INDUSTRIES, INC.·10889942135257·NS 1019 DRAPE KIT

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113652·PS-C Insert, Size 4 x 12mm

Vu cPOD™

FDA UDI
Seaspine Orthopedics Corporation·10889981039356·Implant Non-Tapered 12x14x12mm (Non-Strut)

K2M General Instruments

FDA UDI
VB Spine LLC·10888857553934·Parallel Trial Size 11x30x6 mm

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 29, 2024

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2024

VISTA DIGITAL OPTHALMOSCOPE

FDA 510(k)
FDA Class 2 ·Ophthalmic

FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

IOLMASTER 500

FDA Adverse Event
Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

BD Q-SYTE CLOSED LUER ACCESS DEVICE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·September 16, 2024

COULTER® AC *T DIFF 2 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 21, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·September 18, 2014

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2011

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015