21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES SCALLOPED DISTAL TIBIA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BiOM T2
FDA UDI
BIONX MEDICAL TECHNOLOGIES, INC.·B15520017930·BiOM T2 Battery Charger
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00170931·
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752144767·AirLife™ Volume Ventilator Circuit For Use with...
AirLife™
FDA UDI
AIRLIFE·10889483570524·AirLife™ Volume Ventilator Circuit For Use with...
IPG Medical
FDA UDI
IPG Medical Corporation·00810071230905·IPG Medical, Ball Tip, Single-Use Laser Fiber, ...
PET PIG
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175001806·Pig, Double-Ended, PET, .6" lead, accommodates ...
CANDELA SPTL-1B PULSED DYE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 13, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 3, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 19, 2008
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016