20 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DreamWear Silicone Pillows Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087205·SOLUTION SYSTEM THINSHAFT REAMER 22.5mm DIA
SYMBIA.NET
FDA 510(k)
FDA Class 2
·Radiology
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
LONG NAIL KIT R1.5, LEFT 10X260MM X 125
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2014
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 12, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·July 8, 2013
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018