16 results · 26ms · Sources: EU EUDAMED, US FDA

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SERALYZER TOTAL BILIRUBIN CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Armada

FDA UDI
Nuvasive, Inc.·00887517380869·ARM15T Screw, 5x40mm Fixed

MEGA PLUS MIS SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809916496110·Long-arm Multi-Axial Fenestrated Screw, Ø5.0 x ...

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137367·

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106662·HABERLE-MCPHERSON FORCEPS

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930515·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931611·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932717·Percutaneous Transluminal Angioplasty Balloon C...

PRESSURE GAUGE

FDA 510(k)
FDA Class 1 ·Anesthesiology

CONCEPT DEFRERE ELECTRODE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 3, 2012

VANGUARD PS TIB BRG 10X79/83MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 10, 2025

3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016

TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·May 20, 2015