18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PINPOINT
FDA 510(k)
FDA Class 2
·Radiology
ABL510 BLOOD GAS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONAGHAN AEROCHAMBER WITH MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 28, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 3, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
TPRLC 133 MP TYPE1 PPS SO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 18, 2025
TPRLC 133 T1 PPS SO 13X146MMTP
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 FP TYPE1 PPS SO 5.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 MP TYPE1 PPS HO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 18, 2025
TPRLC 133 MP TYPE1 PPS SO 17.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 MP TYPE1 PPS HO 17.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 MP TYPE1 PPS SO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 18, 2025
TPRLC 133 MP TYPE1 PPS HO 15.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 T1 PPS SO 17X154MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 MP TYPE1 PPS SO 15.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
TPRLC 133 MP TYPE1 PPS HO 12.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 18, 2025
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016