10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334000172·No-slip tip urethral suture guide
AVR Super-Slide Mitral Valve Retractor
FDA UDI
KOROS U.S.A., INC.·10840199538383·AVR Super-Slide Mitral Valve Retractor Medium 2...
MARQUEST QC-IV TONOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BAKER CKMB REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REALSEAL SE
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·June 25, 2014
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 3, 2013
RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code LIT·November 5, 2010
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014