18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
FDA 510(k)
FDA Unclassified
·Unknown
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000332·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000325·
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 6, 2026
Y.E.S POWERED WHEELCHAIR. T180
FDA 510(k)
FDA Class 2
·Physical Medicine
RMS SUBCUTANEOUS NEEDLE SET
FDA 510(k)
FDA Class 2
·General Hospital
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101177·L CR E-MAXTM Vitamin E Ultracongruent Tibial In...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124251·L Ultracongruent Tibial Insert Trial Sz C 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102037·L CR MAXTM HXL Ultracongruent Tibial Insert Sz ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164509·L Ultracongruent Tibial Insert Trial with Anter...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144662·L CR UHMWPE Ultracongruent Tibial Insert Sz C 12mm
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
ARIS TRANS-OBTURATOR KIT
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FTL·May 29, 2013
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·June 17, 2011
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 26, 2023
PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 26, 2023
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024