31 results · 23ms · 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.

BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

AquaGuide® Ureteral Access Sheath

FDA UDI
C. R. Bard, Inc.·00801741052569·AquaGuide® Ureteral Access Sheath

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046039·PrimaLIF LLIF PEEK Implant, 11mm X 22mm X 35mm,...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197030779·Fomon dissecting scissors 135mm,...

POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)

FDA 510(k)
FDA Class 1 ·General Hospital

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 14, 2023

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 18, 2001

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 7, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 21, 2022

AQUAGUIDE® URETERAL ACCESS SHEATH

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FED·July 19, 2023

PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·August 31, 2018

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HRS·April 14, 2015

UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJC·January 5, 2010

SPRINT

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·August 21, 2013

3DKNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·May 23, 2013

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

LCS MENIS BEARING STD+/10MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·August 20, 2008

Cervical Tray Catalog 1089

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

Lumbar Tray Catalog 1091

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022