21 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV
Premium Tray
FDA UDI
Denplus Inc·D8451121214·Cold-cured acrylic resin, Pink, 2.3 kg
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138186385·ALL ELASTIC SACRAL SUPPORT, DUAL ADJUST, BLACK...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776398019·TC Microvascular Needle Holder 9"
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450644706·
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521212140·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377511·Integra® Jarit® Microvascular Needle Holder, 9"...
GUARDIAN CONNECTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
FDA 510(k)
FDA Class 2
·Neurology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197381086·SC Facelift Scissors acc. to Boettler
reinfo...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197381093·SC Facelift Scissors acc. to Boettler
reinfo...
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 20, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 23, 2014
UNKNOWN DEPUY 32MM INSET PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·June 1, 2011
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·January 30, 2025
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024