19 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OsteoFlo® HydroPutty
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Sbo Hearing A/S·05714464033133·Alpha 5 FW 1.1.0
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022149·FPS Plate Cutter Assembly
Orfit Industries
FDA UDI
Orfit Industries NV·05420028755433·Anti-tilt iBeam® Couch Fixation for SBRT short ...
ELMED
FDA UDI
ELMED INCORPORATED·00842180187382·2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMA...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776206925·HOFFMAN SHUNT PASSER LONG
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506061110·2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMA...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506075469·2PC SHUNT PERITONEAL CATHETER PASSER W/ SMALL R...
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
DropSafe Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
FDA 510(k)
FDA Class 2
·General Hospital
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
UNK_ULTRACISION HARMONIC FOCUS
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 20, 2019
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 14, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 1, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022