25 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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2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ArgenZ HT+ 98x30 A2-L
FDA UDI
ARGEN CORPORATION, THE·D818122112·Dental porcelain/ceramic restoration kit
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113447·PS-C Insert, Size 1 x 12mm
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973097·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
CRITICOOL PRO
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·June 30, 2003
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CGA·February 5, 2001
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 21, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·May 24, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 14, 2008
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 13, 2022
I-STAT CG8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·February 26, 2018
ACCU-CHEK INFORM II TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 26, 2024
OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·November 23, 2022
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
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