19 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Normal Saline Flush
FDA 510(k)
FDA Class 2
·General Hospital
AGXO
FDA UDI
Oticon A/S·05707131284860·H150V2, MINIRITE 312 WL DBL AGXO
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197540346·Caspar Rongeur downwards angled 3x12mm 1
40mm
OMNIPRO SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PILOT DIODE LASER, MODEL 002-00139
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SERVO VENTILATOR 300
FDA Adverse Event
Malfunction
·SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION·Product code CBK·May 16, 2003
PLATE COLUMBIA AG 5PRCT SB 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code KZI·August 31, 2023
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 18, 2010
BD NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 18, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 6, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 6, 2011
AES ULTRA
FDA Adverse Event
AES , INC·Product code CAE·August 20, 2008
VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 15, 2017
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 4, 2014
STEM: AMISTEM H HA COATED LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 29, 2019
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024