9 results
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28ms
·
Sources: EU EUDAMED, US FDA
AVL 988-4 ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869437020·arthroscopic iron punch, working length 3 5/8" ...
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Arthrex Blunt Tip Screws with Fiber Tape
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA PLI XLK INS 2.5 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·June 18, 2021
REM 2000 35X80 DARTEX NO FB
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code IKY·February 5, 2013
ON-Q C-BLOC SAF PUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·December 15, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015