15 results · 22ms · Sources: EU EUDAMED, US FDA

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REACH SURGICAL STAPLERS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ARGEDENT 52 (5 dwt)

FDA UDI
ARGEN CORPORATION, THE·D818120179·Gold based noble metal

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201790·Basic Endoscopy Procedure Kit

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197412117·KNAPP iris scissors, curved, 105mm,...

ENVIEW (TM)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPAPLUS

FDA 510(k)
FDA Class 2 ·Immunology

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 19, 2004

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 24, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 26, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 25, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·February 9, 2011

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015