11 results
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18ms
·
Sources: EU EUDAMED, US FDA
BAKER DIAG. ULTRARATE CHLORIDE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM
ACUMED
FDA UDI
Acumed LLC·10806378091216·4.0/4.5mm Screw Sizer
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076875·
BEHRING COAGULATION SYSTEM, MODEL BCS
FDA 510(k)
FDA Class 2
·Hematology
ALCO TUBE PLUS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Injury
·ABBOTT MANUFACTURING INC·Product code JJE·April 4, 2019
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021