11 results · 22ms · 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.

JET VENTILATOR/JETTING DEVICE

FDA 510(k)
FDA Class 2 ·Anesthesiology

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122925·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 150mm

BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM

FDA 510(k)
FDA Class 1 ·General Hospital

AUROPAL 60

FDA 510(k)
FDA Class 2 ·Dental

SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code LMG·July 31, 2019

INRATION PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO INC·Product code GJS·May 28, 2014

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·January 11, 2013

8800

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 8, 2010

UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

FDA Adverse Event
Injury ·AMO MANUFACTURING NETHERLANDS·Product code KYF·July 14, 2022

PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2019

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022