18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
INFLATABLE BONE TAMP
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I
AMARA
FDA UDI
Respironics, Inc.·00606959012851·Amara Mask with RS Frame without Headgear, USA,...
NA
FDA UDI
Conmed Corporation·10845854003374·MICRO TAPERED FISSURE BUR, SHORT 1.2 X 4.5MM, Q...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BUILD-IT FR
FDA 510(k)
FDA Class 2
·Dental
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
FORTIFY ASSURA VR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 15, 2014
HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTS·April 11, 2011
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·February 13, 2024
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