27 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.

B. BRAUN NERVE BLOCK CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

Hegar 8pc Dilator Set

FDA UDI
MEDGYN PRODUCTS, INC.·M803030830·Hegar 8pc Dilator Set 3-4mm - 17-18mm

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA UDI
TENON MEDICAL, INC.·B74240308300·10mm Insertion Screw

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20308301·BioStarter wires Straight-Arch-F. max. .012"

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0380300·Handle, Threaded In Line, Plastic M8

ENT ENDOSCOPES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017

BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017

GYNECARE X-TRACT MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·April 2, 2013

FIRST PICC KIT W/ INTROSYTE-N INTRODUCER

FDA Adverse Event
Malfunction ·ARGON MEDICAL DEVICES INC.·Product code LJS·March 22, 2011

FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 17, 2008