27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental diode laser, SOGA Laser, ILaser II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P2111503·Pro Advantage Electrode Tip Dermal Blunt Sterile
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm
Ormco
FDA UDI
ORMCO CORPORATION·00889989031232·COMPRESSION SPRING TMA 115X60 PK3
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221048882·Unitek(TM) Permachrome Standard Stainless Steel...
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41432111500·Titanium TLIF Spacer, 32 x 11 x 15mm, 0 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40432111500·PEEK TLIF Spacer, 32 x 11 x 15mm, 0 deg
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·December 9, 2024
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 13, 2002
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
FDA 510(k)
FDA Class 2
·General Hospital
DRIDAU OPIATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PUMP MMT-515NAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 24, 2008
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 8, 2011
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6
FDA Adverse Event
Malfunction
·MIS IMPLANTS TECHNOLOGIES LTD.·Product code NHA·September 4, 2024
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015