15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIM 4.0 (NEURO
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
SHARP BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·April 16, 2013
LUPINE DRILL BIT
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HTW·March 11, 2011
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·June 12, 2008
GEMSTAR 1.2 MICRON FLTR 244CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023
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