22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stryker ProCinch Adjustable Loop Device
FDA 510(k)
FDA Class 2
·Orthopedic
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828181792·GEN4 DIGITAL
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706305·Knapp Retractor 5-1/4" (13.3cm), 6mm wide, 4 bl...
Prelude IDeal™ Hydrophilic Sheath
FDA UDI
Merit Medical Systems, Inc.·00884450532768·
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C30422100780·PEEK PLIF Spacer, 22 x 10 x 7mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C31422100780·Titanium PLIF Spacer, 22 x 10 x 7mm, 8 deg
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
FDA 510(k)
FDA Class 1
·General Hospital
EXTRICARE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069914528·WIDEX MOMENT MRB2D (Mediterranean turquise ) 11...
Widex
FDA UDI
Widex A/S·05706069691863·Widex BEYOND B-F2 (Mediterranean turquise ) 110...
Widex
FDA UDI
Widex A/S·05706069827323·WIDEX EVOKE EBB3D (Mediterranean turquise ) 110...
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 23, 2023
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 29, 2014
ABGII NO3 CEMENTLESS RIGHT V40
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024