15 results
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20ms
·
Sources: EU EUDAMED, US FDA
ZIRKONDENT
FDA 510(k)
FDA Class 2
·Dental
TruForm
FDA UDI
Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100
TensCare
FDA UDI
TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...
BD
FDA UDI
PRYOR PRODUCTS·00761887000483·6 leg, pmp adap, O2 rings, 4 outlet, 4 hook, sw...
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102832·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
ENA EIA KIT RANGE
FDA 510(k)
FDA Class 2
·Immunology
SERRALNYL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3004753838-2018-080146
FDA Adverse Event
Malfunction
·July 20, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 30, 2012
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·October 21, 2025
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 6, 2011
DUR MAR +4 NEUT LNR 36X54
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code LPH·July 18, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024