30 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IsoPSA Assay
ReLine
FDA UDI
Nuvasive, Inc.·00195377047311·RELINE-O Trial, 12mm H TP W L-pop
Potts Smith Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896118522·Potts Smith Forceps With Stop Pin & Round Disse...
VASER
FDA UDI
SOLTA MEDICAL·00816995027409·FS, GEM, ULTRASOUND, YELLOW, V2.0
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828139489·GEN4 DIGITAL
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828159043·GEN4 DIGITAL
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
FDA Pre-Market Approval
FDA Class 3
·NeuRX Diaphragm Pacing System (DPS)
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·DORNIER EPOS ULTRA
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 14, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 14, 2022
MectaLIF Anterior Simple
FDA 510(k)
FDA Class 2
·Orthopedic
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205001073·High-density veterinary transducer type – phase...
HYPERFORM OCCLUSION BALLOON SYSTEM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MJN·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
BENGAL IMPLANT STD 5MM 7 DEG
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code MQP·July 1, 2013
TPRLC 133 FP TYPE1 PPS SO 7.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWL·December 1, 2021
32MM COCR BIOMET FEM HD -3 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 30, 2025
FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·January 22, 2020
WAGNER CONE PROSTHESIS, 135, UNCEMENTED 14, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 17, 2018
PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
FDA Adverse Event
Death
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·September 24, 2020