16 results
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26ms
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Sources: EU EUDAMED, US FDA
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