17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HY-CHLO(TM)WOUND SCRUB
FDA 510(k)
FDA Class 2
·General Hospital
7500 V MASK
FDA UDI
HANS RUDOLPH, INC.·00874750000029·7500 SMALL 22OD ELB W/STD HDGR
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016135·ROD CONNECTOR, PARALLEL CLOSED 12mm OFFSET, Ø 5...
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
UPD-Y0003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
CONNECSCR F/INSERTION DHS BLADE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code LXH·May 15, 2013
DUR MAR NEUT LINER 28IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011
TRIATHLON #3 CR INSERT 9MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 12, 2008
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL
FDA Adverse Event
Malfunction
·MAQUET GMBH·Product code FQO·January 16, 2024
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025