21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Centro Vena Acute Central Line (7 French Dual Lumen)
FDA 510(k)
FDA Class 2
·General Hospital
Navigator 3 Wired Probe, 13mm Straight
FDA UDI
crystal-photonics GmbH·04260152884415·Gamma probe system, straight wired probe
FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060715·FORCEPS EXTRA LONG STRAIGHT TUNGSTEN CARBIDE DU...
TMC SpeedMTP
FDA UDI
Treace Medical Concepts, Inc.·00810111223669·Inserter Cap
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034494·Profile Zero Organizer Block
NELSON-METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083585·NELSON-METZENBAUM SCISSORS CURVED BLADE POWER C...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837043·AK Thyroidectomy Blade 35mm x 110mm with Suction
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159007664·Dennis Anastomosis Clamp
BALANCE MICROPLASTY BROACH
FDA UDI
Biomet Orthopedics, LLC·00880304459311·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694091695·Lid, Organizer Block, Profile Zero
INION CPS BSSO SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 22, 2016
AXS VECTA 074 CATH 132CM - CE
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·July 16, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 1, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014