21 results · 24ms · Sources: EU EUDAMED, US FDA

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ES-160

FDA 510(k)
FDA Class 2 ·Neurology

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00510201·

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821051020·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

MBA™ Titanium Subtalar Implant System

FDA UDI
Ascension Orthopedics, Inc.·10381780280484·MBA™ Titanium Subtalar Implant System CANNULATE...

Subtalar MBA Implant System

FDA UDI
Smith & Nephew, Inc.·00885556866030·DRIVER FOR TITANIUM MBA ONLY 3.5MM HRX

MicroAire®

FDA UDI
Microaire Surgical Instruments LLC·00847399004987·SST TWIST DRILL, DENTAL, 2mm Dia. x 65mm

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138102989·STANDARD LATEX FREE WOVEN ELASTIC BANDAGE 2INX4...

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180500507·Curved Thoracic Gear Shift, Radel Handle

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00811801030383·Curved Thoracic Gear Shift, Radel Handle

ENDO LINEAR CUTTERS-ECHELON 60MM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

8100 VITAL SIGNS MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

PROTECTA XT DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 10, 2013

ESPRIT VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 12, 2011

TENDRIL DX

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

REF H10

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

FDA Enforcement
Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020