13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIM-Thin Client (mobile)
FDA 510(k)
FDA Class 2
·Radiology
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017764·CASTROVIEJO NEEDLE HOLDER WITH LOCK CURVED TUNG...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017719·CASTROVIEJO NEEDLE HOLDER WITH LOCK CURVED TUNG...
POWDERED LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
FDA 510(k)
FDA Class 2
·Dental
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER
FDA Adverse Event
Injury
·ACCLARENT·Product code KAM·October 6, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
ENDOPATH** XCEL* BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 7, 2013
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014