16 results · 22ms · Sources: EU EUDAMED, US FDA

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ELECSYS TROPONIN T

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

K-Systems

FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120307·Assisted Reproduction Accessories

P.F.C. SIGMA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295239178·P.F.C. SIGMA TC3 TIBIAL INSERT TRIAL SZ 1.5 10m...

Needle Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668108116·CASTROVIEJO NEEDLE HOLDER STR W/ LOCK

Eye Shield

FDA UDI
KATENA PRODUCTS, INC.·00841668111185·PIN HOLE EYE SHIELD WHITE PACK OF 12

MICROSPAN SYSTEM

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code FED·June 8, 2006

MEG-TORQ

FDA 510(k)
FDA Class 1 ·Dental

SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

CLXECP KIT

FDA Adverse Event
Injury ·THERAKOS·Product code LNR·September 16, 2009

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 14, 2013

SENSORMEDICS

FDA Adverse Event
Malfunction ·CAREFUSION·Product code LSZ·January 10, 2011

ENDOVIVE? JEJUNAL FEEDING TUBE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 28, 2014

SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

FDA Adverse Event
Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

FDA Enforcement
Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

FDA Recall
Open, Classified ·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMZ·December 26, 2023

Philips Zenition 50, Model Number: 718096

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024