12 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.

Percutaneous Nephroscope System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102695·MINARDI PHACO CHOPPER

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 21, 2020

TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·June 27, 2024

CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ion Endoluminal System

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

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011

LINGEMAN UROLOGY/GYN DRAPES

FDA Adverse Event
Malfunction ·MICROTEK DOMINICA, S.A.·Product code KKX·August 27, 2014

HANA OPERATING ROOM TABLE

FDA Adverse Event
Injury ·MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code JEA·November 7, 2012

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024