25 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PowerPICC Provena
FDA UDI
Bard Access Systems, Inc.·00801741137679·Catheter Placement Kit
TEWA
FDA UDI
asia-med GmbH·04251282513337·TeWa PJ-Type 2550: coated acupuncture needles ...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282506346·TeWa PJ-Type 2550: coated acupuncture needles ...
Brite-Gear
FDA UDI
ORMCO CORPORATION·00889989023671·Facebow SHORT #3 044 WHITE
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756236003·ExtendEVAC Electrosurgical Pencil
4WEB Medical
FDA UDI
4web Medical·00810074752039·
SoftTip large
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616001885·SoftTip large R-2414-15 HP/Philips
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
FRIENDLY LIGHT ER:YAG PULSED LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 10, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 17, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·February 21, 2008
MANTA 18F
FDA Adverse Event
Malfunction
·ESSENTIAL MEDICAL, INC·Product code MGB·January 31, 2022
POWERPICC SOLO CATHETER, 5F TL, TT, 3CG
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·June 11, 2018
RIBFIX BLU SYSTEM 16 HOLE PRE-BENT PLATE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·October 31, 2017
ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 26, 2023
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·October 3, 2018
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026