28 results · 25ms · 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.

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Paparella

FDA UDI
MEDTRONIC XOMED, INC.·00613994146106·VENT TUBE 1082201 5PK PAPA TYPE 1.14

Microgel®

FDA UDI
MEDTRONIC XOMED, INC.·00763000037451·VENT TUBE 1082201 5PK PAPA TYPE 1.14

Harvard PremiumFill A1

FDA UDI
Harvard Dental International GmbH·EHAR70822011·Universal light cure nano-hybrid composite for ...

Microgel

FDA UDI
MEDTRONIC XOMED, INC.·00763000870355·VENT TUBE 1082201 5PK PAPA TYPE 1.14

NaturaLyte

FDA UDI
Fresenius Medical Care Renal Therapies Group, LLC·00840861101672·NaturaLyte Liquid Acid Concentrate for Bicarbon...

PREMICRON NONABSORBABLE PET SURGICAL SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

FDA Adverse Event
Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

TOTAL ASR FEM IMP SIZE 51

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 9, 2011

DASH 4000

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code MHX·July 22, 2008

PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020

PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019

PREMICRON GREEN 2/0 (3) 30CM SKR19(M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020

PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021