13 results · 22ms · Sources: EU EUDAMED, 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