22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
FDA 510(k)
FDA Class 2
·Hematology
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310210243·FG Diamond 801-014 ball regular 5/pack
ROLLO 210X20X19E.DELTA 60 PLUS
FDA UDI
AB MEDICA GROUP, S.A.·08428763036685·
MICROPOWER
FDA UDI
Conmed Corporation·20845854013196·MICROPOWER OSCILLATOR SAW, PERMANENT LEVER
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005275·COSMETIC 20/40 UL LAT 022 T+8 A+9 R=0
MICROPOWER
FDA UDI
Conmed Corporation·10845854013199·Micropower Oscillator Saw, Permanent Lever
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CYBERKNIFE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
CVC SET: 4-LUMEN 8.5FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·March 20, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·March 16, 2011
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER LTD. (HAIFA, ISRAEL)·Product code DQK·March 27, 2008
PENUMBRA SMART COIL
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2017
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
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 29, 2021
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026