22 results · 23ms · Sources: EU EUDAMED, 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