21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
FDA 510(k)
FDA Class 2
·Cardiovascular
Test Chambers for Irrigation/Aspiration Cannulas
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896107847·Test Chambers for Irrigation/Aspiration Cannulas
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J0111631131000·CONTEC lc primer / adhesive / For CONTEC lc bra...
EP-WORKMATE
FDA 510(k)
FDA Class 2
·Cardiovascular
VASCULAIRE COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 17, 2022
CORTICAL BONE SCREW, ÿ 4X32MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
BLUNT TIP SCREW, ÿ 4X44MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
CORTICAL BONE SCREW, ÿ 4X30MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
BLUNT TIP SCREW, ÿ 4X48MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 1, 2015
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Malfunction
·ETHICON·Product code FTL·July 15, 2011
LEAD MODEL 304
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 11, 2013
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·September 16, 2008
BLUNT TIP SCREW, ÿ 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
PROXIMAL HUMERUS NAIL CAP, 0MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·November 7, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 4, 2016
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026