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

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PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)

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

ADULT DUAL-HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 19, 2012

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI

Carbide burs

FDA UDI
DFS - DIAMON GmbH·04057176149022·Ortho carbide bur C219-O CA 1,6

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818615·Malleable Retractor 3" x 7" w/ Protective Edge

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321108160·

DRACO

FDA UDI
HNM TOTAL RECON LLC·00841742122434·DRACO MetaFuse Plantar Plate, Ti - (L)37mm, R

DENTO-PREP PARTICLE MICROBLASTER

FDA 510(k)
FDA Class 2 ·Dental

PK SUPERPULSE SYSEM GENERATOR MODEL 744000

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

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·September 23, 2014

UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 1, 2011

REVITAN, RASP, DISTAL, CURVED, 14/140

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·April 11, 2018

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021