11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
LONG NAIL KIT R2.0, STST, RIGHT 11X360MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·May 25, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
FDA 510(k)
FDA Class 1
·Physical Medicine
STONELIGHT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC.·Product code GEX·October 21, 2008
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
KENTROX SL-S 65/16 STEROID
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·July 8, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025