19 results
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28ms
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Sources: EU EUDAMED, US FDA
AGFA CR50.0
FDA 510(k)
FDA Class 2
·Radiology
Batrik Brush/Blue/BD 8+10mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007789·Brush/Blue/BD 8+10mm/BL 50mm/OL 50cm - Asymetri...
Neo-Tee T-Piece Resuscitator
FDA UDI
MERCURY ENTERPRISES, INC.·10641043508107·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450253083·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139417·
Life Instruments
FDA UDI
Life Instrument Corporation·M9307050810010·Knife Blade Holder Str 5/8" Alum Handle
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 10, 2013
RIATA ST OPTIM ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
FDA Enforcement
Class I
·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·January 22, 2025
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
FDA Recall
Open, Classified
·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·December 10, 2024
Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.
FDA Recall
Terminated
·Stryker Endoscopy·Product code LMD·December 11, 2009
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
FDA Enforcement
Class II
·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016