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

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BIOPRO POLAR HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

SampLok® Adapter Cap 3 Insert

FDA UDI
ITL ASIA PACIFIC SDN. BHD.·09555240401533·SampLok® Adaptor Cap 3 (SAC 3) Insert is an opt...

Oticon

FDA UDI
Oticon A/S·05707131165527·ACTO, ITC/ITE AP BE

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450480496·

Meritrans®

FDA UDI
Merit Medical Systems, Inc.·00884450048542·

Indus®

FDA UDI
SPINEFRONTIER, INC.·00190361001430·Invue Max, Four Level ACP, 61mm

UA Impression Sleeve

FDA UDI
BICON, LLC·00813110027016·UA6 LP Impression Sleeves (3)

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494464218·Cup Forceps Straight Jaw D 5.0mm, WL 150mm

CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX

FDA 510(k)
FDA Class 2 ·Orthopedic

SPL-50 SPIROLYSER

FDA 510(k)
FDA Class 2 ·Anesthesiology

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·December 17, 2010

VOYAGER NC CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·December 4, 2008

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 19, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2011

EMAG®

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJH·May 29, 2018

Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

FDA Enforcement
Class II ·Terminated·Abbott Vascular·February 6, 2013

CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

FDA Enforcement
Class II ·Terminated·CME America, LLC·December 9, 2020

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025