21 results
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28ms
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Sources: EU EUDAMED, US FDA
BIOTEST HEMOGLOBIN MEASURING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540602580·Bone Screws, MP, Cross-Pin
Elastomull®
FDA UDI
BSN MEDICAL, INC.·00035664020712·ELASTOMULL STERILE 10CMX3.75M 12
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231413·Unitek Miniature Twin MBT LL Cus 0T/3A DHk 022 ...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009885·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009984·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837050740·10mmx20mmx10mm Plateau-P, 7 Degree Reverse Angle
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0107100·Tamp, Rotating
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023796·Angled Tamp
MD 10, SEM, SM 12, CBM
FDA 510(k)
FDA Class 1
·Dental
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC·Product code LNM·October 17, 2012
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LNM·October 17, 2012
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 18, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code LXH·March 16, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
THE ELECTRODE STORE
FDA Adverse Event
Malfunction
·THE ELECTRODE STORE·Product code GXZ·July 17, 2021
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·April 17, 2025