13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cohitech Reusable Tampon Applicator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Oticon
FDA UDI
Oticon A/S·05707131376169·OPN S 1, MINIRITE 312 2.4G NFM PB C091
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586040238·
DSJ MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
STERILE NITRILE SURGICAL GLOVES (POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·April 2, 2007
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 9, 2013
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·July 15, 2025
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017