18 results · 22ms · Sources: EU EUDAMED, US FDA

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GAM-200

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III

ARGENCO BIO 1 (5 dwt)

FDA UDI
ARGEN CORPORATION, THE·D818120243·Gold based noble metal

JOBST soSoft

FDA UDI
BSN MEDICAL, INC.·00035664007492·SOSOFT 8-15 MM HG KNEE HIGH BROCADE SMALL WHITE...

DRIVEMEDICAL

FDA UDI
Drive Devilbiss Healthcare·50822383729157·Bath SafetyGrab Bars Product Description: GrabB...

DRIVEMEDICAL

FDA UDI
Drive Devilbiss Healthcare·00612479224292·Bath SafetyGrab Bars Product Description: GrabB...

ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CEK·August 11, 2023

QUINTEX CERVICAL PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LASERPRO 16

FDA 510(k)
FDA Class 2 ·Radiology

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

TROJAN PLEASURE PACK LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEK·March 10, 2023

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013

XENMATRIX

FDA Adverse Event
Injury ·DAVOL INC.·Product code FTM·May 31, 2011

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 14, 2008

ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CEK·August 14, 2023

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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