21 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Bernafon AG·05711584114087·CZ5 B 105, 2.4G NFM SABE DEMO CORAL 5 GPL
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331155734·brown needle holder, convex jaws, fine serratio...
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22312126240·Fukasaku Hockey Knife BW 3mm OL 120mm (4 3/4")
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
FDA 510(k)
FDA Class 2
·Orthopedic
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 17, 2025
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024
SMARTSET HV BONE CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·October 24, 2008
UNKNOWN ZIMMER ACETABULAR LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·August 11, 2011
AUTOLUBE-III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEI·July 9, 2013
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FPA·April 20, 2026
Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.
FDA Recall
Terminated
·ArjoHuntleigh·Product code FSA·April 27, 2009
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