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

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PICCOLO MAGNESIUM TEST SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Premier

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040115·RING PESSARY W/O SUPPORT #5

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001854·Wrist Splint

HiRise

FDA UDI
CURVEBEAM, LLC·00860004550020·CBCT upper & lower extremities including the pe...

20GA Curved Illuminating Probe, SMA906

FDA UDI
Peregrine Surgical, Llc·00632307002014·20GA Curved Illuminating Probe, SMA906

n/a

FDA UDI
Ortho Development Corporation·00822409073818·10/12 Resection Guide 30degx15mm

Arthrex®

FDA UDI
ARTHREX, INC.·00888867522107·Cannulated Cancellous Screw, 7.0x115mm

BD ULTRA-FINE¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022

Toilet Support Arms

FDA UDI
Ropox A/S·05707581000287·

REFLEX ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RETIC CHEX LINEARITY

FDA 510(k)
FDA Class 2 ·Hematology

12/14 ARTICUL 40MM M SPEC-2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013

2124215-2011-00478

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code NVN·April 5, 2011

ARTICUL/EZE BALL 32 + 1 GR

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code JDI·May 7, 2008

ULTRA 2 CUTTING BALLOON

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010

Stryker Epic Zoom Critical Care Bed -Model 2040, 115 V, 500 lbs ( 227 Kg) Stryker, Portage Mi 49002 Product Usage: EPIC II (model 2040) Critical Care beds is primarily used in a Critical Care environment, but may be used in Med/Surg environments.

FDA Recall
Terminated ·Stryker Medical Division of Stryker Corporation·Product code FNL·March 12, 2012

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020