17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNO SLA Mini Plus® Implant System
FDA 510(k)
FDA Class 2
·Dental
MEDLINE ANTI-EMBOLISM STOCKING
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 22, 2003
CORAIL2 STD SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575·Product code KWA·July 6, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·May 26, 2026
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·November 5, 2014
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 17, 2011
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·July 18, 2013
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 19, 2025
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·October 10, 2025
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 19, 2025
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
FDA Enforcement
Class II
·Terminated·Acumed LLC·May 7, 2014
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021