21 results · 23ms · Sources: EU EUDAMED, 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