15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXIOM VESSEL LOOPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950022380·CALIPER CASTROVIEJO SHORT BEAK STRAIGHT 0-20MM ...
0800,APS1,08,N,RM LT,ON/OFF,RD LT ON/OF
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828149228·0800,APS1,08,N,RM LT,ON/OFF,RD LT ON/OF
HEARTLINE MINI JAW NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896006782·HEARTLINE MINI JAW NEEDLE HOLDER WITH LOCK TUNG...
HEARTLINE MINI JAW NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·B09928000150·HEARTLINE MINI JAW NEEDLE HOLDER WITH LOCK TUNG...
Biofill applicator
FDA UDI
Human Med AG·04260170881151·Biofill applicator, accessory for body-jet evo/...
Rampart O
FDA UDI
SPINEOLOGY INC.·M7402800015·11x30mm Trial
BARCOMED 2MP2
FDA 510(k)
FDA Class 2
·Radiology
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
FDA 510(k)
FDA Class 2
·Immunology
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORPORATION·Product code DSP·January 15, 1998
APPOSE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GDT·April 23, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 17, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021