12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL™ Mueller Hinton II Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902122579·BD BBL™ Mueller Hinton II Agar, 25 lb
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982152411·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 2 LAT
FDA Adverse Event
Other
·MEDACTA INTERNATIONAL, SA·Product code LZO·July 29, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
FLEXIMA¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FGE·August 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
BD BBL¿ MUELLER HINTON II AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·August 12, 2022
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 6, 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