14 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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MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033614·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037304679·TRIAL HUMELOCK REVERSED STEM Ø36/14
TROJAN CRYSTAL CLEAR LIQUID
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
SIMPLEX P FULL DOSE 1 PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·April 3, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code LTI·February 11, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·April 24, 2008
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HSB·January 22, 2017
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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