15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ADVANCE TM T-3 UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AltiVate® Anatomic Shoulder AG e+ with Markers
FDA 510(k)
FDA Class 2
·Orthopedic
INSTINCT JAVA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·November 27, 2007
ALTRX NEUT 32IDX58OD
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·November 7, 2012
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018