15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Disposable sterile needle retractable safety syringe
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613021238·Toynbee Infant Speculum, Oval, 2.5mm x 3.5mm Di...
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS SHBG CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CABLE TENSIONER
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 3, 2018
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 22, 2019
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 22, 2019
CABLE TENSIONER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·August 18, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·June 1, 2011
POSTERIOR CHAMBER LENS
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 28, 2008
INTIMA-II 20GAX1.16IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FPA·September 16, 2019
CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022