16 results · 27ms · Sources: EU EUDAMED, US FDA

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RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

FDA 510(k)
FDA Class 2 ·Neurology

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293500·

NA

FDA UDI
KEY SURGICAL, INC.·10849771049675·Steinmann Pins, Single trocar, 3 shank end, 7/6...

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771013075·Steinmann Pins, Single trocar, 3 shank end, 7/6...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484894·Steinmann pin w. trocar/3-shank _x000D_...

Steinmann pin w. trocar/3-shank 2.8mm/229mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM714860·Steinmann pin w. trocar/3-shank 2.8mm/...

Q-RAD RADIOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

GENX CODA AIR PURIFICATION SYSTEM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 22, 2013

ASR ACETABULAR CUPS 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 15, 2011

CONTOUR TEST STRIPS (10)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 2, 2008

135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2H-STER

FDA Adverse Event
Malfunction ·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code KTT·January 19, 2018

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012