22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TiWAVE-L Porous Titanium Lumbar Cage
FDA 510(k)
FDA Class 2
·Orthopedic
Monoject
FDA UDI
Cardinal Health 200, LLC·10192253025026·Hypodermic Safety Needle 22G x 1" (0.7 x 25 mm)
Monoject
FDA UDI
Cardinal Health, Inc.·10884521544642·Hypodermic Safety Needle
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269590·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513189·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026919·Deaver Retr, hollow grip hndl, 2"x12"
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154041·COSMETIC SL EMPOWER CLEAR INTERACT UL LAT 018 T...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746199929·COSMETIC SL EMPOWER CLEAR INTERACT UL LAT 018 T...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000270·COSMETIC SL EMPOWER CLEAR INTERACT UL LATERAL 0...
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T:SLIM G4 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·December 7, 2016
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 15, 2023
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
11.0MM TI HELICAL BLADE 105MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·June 21, 2013
ACTIVA PC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 7, 2011
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·October 17, 2014
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 30, 2024
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021