18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
NexxZr™ T / D-100-22-NT-B200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112835·
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488127163·STERILE NERVE BLOCK TRAY
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
FDA 510(k)
FDA Class 2
·General Hospital
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 10, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 16, 2011
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
FDA Recall
Terminated
·Plus Orthopedics USA·Product code KTT·June 30, 2003
UNK - CONSTRUCTS: FNS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·December 29, 2023
UNK - CONSTRUCTS: DHS/DCS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·December 29, 2023
UNK - PLATES: FNS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·December 29, 2023
UNK - CONSTRUCTS: DHS/DCS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·December 29, 2023
UNK - SCREWS: FNS LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·December 29, 2023
UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·December 29, 2023
UNK - NAIL HEAD ELEMENTS: FNS BOLT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·December 29, 2023
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024