9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Hemoclip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 12, 2021
IMMULISA SCI-70 ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
BENZODIAZEPINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HOMECHOICE INTEGRATED APD SETWITH CASSETTE 3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 29, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
SENSATION 7FR, THE CS 300 WITH INTELLISENSE
FDA Adverse Event
Injury
·DATASCOPE·Product code DSP·July 1, 2013
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 11, 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