22 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
FDA 510(k)
FDA Class 2
·Anesthesiology
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062048·Mini Uni-Twin(TM) Bracket APC(TM) II UL1 17T/5A...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093066·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL1 17T/...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016133·Mini Uni-Twin(TM) Bracket UL1 17T/5A .018 5/Pk
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157695·
PROMA, INC.
FDA registration
PROMA, INC.·2 products·🇺🇸 United States
BRACHYSEED
FDA 510(k)
FDA Class 2
·Radiology
REPLACE TPS COATED IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
BERLIN HEART EXCOR PEDIATRIC VAD
FDA Adverse Event
Injury
·BERLIN HEART GMBH·Product code DSQ·June 17, 2021
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021
NEEDLE 30X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023
PEN NEEDLE AUTOSHIELD DUO 30GX5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 9, 2021
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023
NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 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