20 results
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21ms
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Sources: EU EUDAMED, US FDA
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Silicone Round Drain
FDA UDI
C. R. Bard, Inc.·00801741049460·Silicone Round Drain, Medium 1/8" (10Fr., 3.2mm...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697933·Fully Guided Drill Ø5mm L20mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180502082·PLIF/TLIF Rotating Disc Shaver/Distractor Combo...
WOUND DRAINAGE
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·September 14, 2022
PVC DRAIN WITH TROCAR
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022
PVC DRAIN WITH TROCAR
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022
PVC DRAIN WITH TROCAR
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·August 25, 2022
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742111315·LYNX ø4.0mm Cancellous Screw, Full Thread, Ti -...
BARD WOUND DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022
MODIFICATION TO TRIDENT ALL POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
VOYAGER 6.0 SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Neurology
SILICONE ROUND DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·February 10, 2025
SILICONE ROUND DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·May 17, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
COROX OTW 85-BP
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NKE·April 18, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008
CLOSED WOUND SUCTION
FDA Adverse Event
Injury
·C.R. BARD INC. (COVINGTON) -1018233·Product code GCY·March 7, 2025
RELIAVAC CLOSED WOUND SUCTION EVACUATOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·August 16, 2019
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024