25 results
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19ms
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Sources: EU EUDAMED, US FDA
LDH (L-P) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750000593·VITROS Chemistry Products UPRO Slides
Helix
FDA UDI
Nuvasive, Inc.·00887517134493·Helix R Plate, 20mm 1-Level
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDI
THD SPA·08033737710579·The THD Light-Scope rectoscope is a disposable ...
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D9098001201·MATHIEU NEEDLE HOLDER W/ SAFETY LATCH - FINE TIP
ACUMED
FDA UDI
Acumed LLC·10806378040030·Universal Tray Base
Opaque
FDA UDI
Kerr Corporation·00841396107962·Resin Based Dental Restorative Material - C2
PENILE IMPLANT
FDA Adverse Event
Injury
·DACOMED·Product code FAE·February 15, 1995
Electrode
FDA UDI
SOPRO-COMEG GmbH·04059082009728·
PRO-TORQ
FDA 510(k)
FDA Class 1
·Dental
HFO SHOULDER COIL
FDA 510(k)
FDA Class 2
·Radiology
DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS
FDA Adverse Event
Malfunction
·DACOMED CORP.·Product code FAE·May 13, 1994
530G INSULIN PUMP MMT-751NAH
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2018
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
INOMAX DS (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·August 10, 2010
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·February 15, 2017
HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V
FDA Adverse Event
Malfunction
·CONMED LARGO·Product code GEI·August 11, 2023
Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.
FDA Recall
Terminated
·Biokit U.S.A. Inc.·Product code LGC·April 14, 2010
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013