16 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SPINAL ELEMENTS CERCLAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Support cushion comfort Breast BI 7

FDA UDI
Noras MRI products GmbH·04251269207013·The support cushion serves as a comfortable res...

Support cushion comfort Breast

FDA UDI
Noras MRI products GmbH·04251269206931·The support cushion serves as a comfortable res...

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201770·Endoscopy Basic Procedure Kit

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197031981·KNAPP iris scissors, curved, blunt 10.5cm

SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

HELENA SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FASTTAKE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 16, 2003

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 2, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 22, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

SECURE 3 MED/SURG BEDOBS 01/13

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013

DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 25, 2014

LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·June 6, 2011

INSERTION DEVICE FOR ZERO-P VA

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVE·April 24, 2020

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015