22 results
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20ms
·
Sources: EU EUDAMED, US FDA
TORAYSULFONE DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964018945·Endo Carry-On Procedure Kit
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040072585·Steel Bur HP 1
Harvard Cement normal setting, Single powder, Shade 12
FDA UDI
Harvard Dental International GmbH·EHAR70025121·Zinc phosphate cement
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00885074269320·LP12AABCAAAABBABAABAAAAALP12 MONITOR-DEFIB
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523123551·ACP Drill Bit, Ø2.3mm x 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148851·Straight Implant Trial 25mm x 9mm x12mm
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A MAGNUM TPR ADPR TI
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 7, 2012
RECAP SHELL COCR PC 54/48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 7, 2012
BI-METRIC HA/PC 11X135MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·September 7, 2012
M2A MAGNUM MODULAR HD COCR 48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 7, 2012
E1 RINGLOC BIPOLAR SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·March 30, 2020
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013
TRIDENT 0 X3 INSERT 36MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·February 16, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·February 26, 2008
HEALONID GV
FDA Adverse Event
Injury
·PHARMACIA & UPJOHN, FYRISLUND·Product code LZP·January 14, 2002
HEALONID GV
FDA Adverse Event
Injury
·PHARMACIA & UPJOHN, FYRISLUND·Product code MRE·January 14, 2002
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025