25 results · 23ms · Sources: EU EUDAMED, US FDA

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LUMINESSE ZR BLANKS

FDA 510(k)
FDA Class 2 ·Dental

COOLEY MULTI PURPOSE CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002320·COOLEY MULTI PURPOSE CLAMP ANGLED

OsteoMed

FDA UDI
OSTEOMED LLC·00845694001823·10 Hole Straight Rigid Plate

OPERATING SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046719·OPERATING SCISSORS CURVED SHARP/BLUNT BLADES

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037308141·HUMERAL STEM REAMER S8-10

COOLEY MULTI PURPOSE CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002050·COOLEY MULTI PURPOSE CLAMP ANGLED

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063319·2.0 System 10 Hole Straight Rigid Plate Sterile...

ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS

FDA 510(k)
FDA Class 2 ·Orthopedic

PRE-POWDERED NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

M3M4

FDA Adverse Event
Malfunction ·OSTEOMED·Product code DZL·August 21, 2015

RADIFOCUS OPTITORQUE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

CORAIL2 NON COL HO SIZE 16

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LWJ·May 8, 2013

ABBOTT M2000SP

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011

SURSHIELD PUR SAFETY I.V. CATHETER

FDA Adverse Event
Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

OPTITORQUE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·Product code DQO·January 20, 2021

PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

FDA Recall
Terminated ·PTW-Freiburg Lorracher Strasse 7 Freiburg Germany·Product code IYE·May 27, 2015

PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

FDA Enforcement
Class II ·Terminated·PTW-Freiburg·September 2, 2015

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

FDA Recall
Open, Classified ·Smiths Medical ASD, Inc.·Product code FRN·April 10, 2025

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025