20 results · 26ms · Sources: EU EUDAMED, 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