11 results
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25ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE CURETTE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PAQ.210X295X150*28*CARDISMART
FDA UDI
AB MEDICA GROUP, S.A.·08428763009597·
DUPLOCATH
FDA UDI
BAXTER INTERNATIONAL INC.·00085412095646·Duplocath Application Catheter
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158212961·ANOSCOPE IVES-FANSLER 22MMØ X 80MM (3")
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110959·STERILIZING CASE SMALL
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
FDA 510(k)
FDA Class 2
·Hematology
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·November 11, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Enforcement
Class II
·Terminated·Cairn Diagnostics·February 24, 2021