18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
FD TENS 2070
FDA 510(k)
FDA Class 2
·Neurology
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176148155·Bone Cutter type 165 CA
NA
FDA UDI
Smith & Nephew, Inc.·03596010039767·DEEP BLADES FOR SELF-RETAINING
...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199449·SET OF DEEP BLADES SHORT and LONG DEEP
IMPROVIS IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·May 7, 2013
NEATCLOSE SUTURING DEVICE
FDA Adverse Event
Other
·NEATSTITCH LTD.·Product code GAM·June 2, 2011
PRECISE OTW NITINOL STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·August 12, 2008
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LPH·August 20, 2021
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LPH·August 20, 2021
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LPH·August 20, 2021
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LPH·August 20, 2021
UNK HIP FEMORAL STEM CORAIL
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LPH·August 20, 2021
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·August 22, 2016
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024