24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
Procure
FDA UDI
Twin Med, LLC·10840330700341·Mask Adult Aerosol Elongated
TTP-Tuebingen Type BELL Partial Titanium
FDA UDI
Heinz Kurz GmbH·EHKM10022241·Ossicular Prosthesis, partial
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00272241·
Checkcell
FDA UDI
IMMUCOR, INC.·10888234000181·Checkcell is used to confirm the validity of ne...
Mask
FDA UDI
WESTMED, INC.·00709078014352·Mask Adult Aerosol Elongated
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 14, 2020
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOGIC TIBIA PS MOD INSRT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2023
LOGIC FEMORAL PS CEM LEFT SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 3, 2024
GENERATOR PULSAR2
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY, LLC·Product code MUL·March 13, 2013
PINN MAR +4 10D 40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 18, 2011
CORAIL AMT COLLAR SIZE 8
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWA·February 20, 2008
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016