21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ScandiDos Delta4 Phantom+
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131280046·H16, DESIGNRITE 10 WL MOP
Guiding Cylinder NC for Bone Level Bone Profiler
FDA UDI
BIO CONCEPT Co., Ltd.·06947600304449·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192350·Apex Revision Knee Reamer - Zimmer 18mm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100257·CHU ASPIRATING SPECULUM SOLID
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 15, 2021
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197051286·Spencer-Wells Hemostatic Forceps
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197046039·Gerald Tissue Forceps
1x2 te...
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304547·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304554·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304530·Knee femur prosthesis trial - General Instrument
BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·January 4, 2022
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 23, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 3, 2024
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024