14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clear Aligner
FDA 510(k)
FDA Class 2
·Dental
PANALOK
FDA UDI
DEPUY MITEK, LLC·10886705002597·PANALOK Slotted Drill Guide Sawtooth
NA
FDA UDI
Synthes GmbH·10886982153104·3.5MM LOCKING SCREW SELF-TAPPING 26MM
Surge Cardiovascular
FDA UDI
Alliant Enterprises, LLC·00817278010149·Vein graft cannula, blunt tip with check valve
Spex
FDA UDI
SPEX LIMITED·09420051707252·Spex 2-point hip belt, padded, centre pull with...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710502130260·1st Met Sagittal Medial Guide, 13mm x 26mm
POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
FDA 510(k)
FDA Class 1
·General Hospital
M2A 38MM MOD HD +3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 30, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 12, 2011
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 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