20 results · 21ms · Sources: EU EUDAMED, US FDA

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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