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

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ELECTROTORQUE TLC

FDA 510(k)
FDA Class 1 ·Dental

27ga Reusable Maeno-Awh Super Manipulator

FDA UDI
KATALYST SURGICAL LLC·00840096205282·

LOCKE BONE REDUCTION FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896050822·LOCKE BONE REDUCTION CLAMP WITH LONG RATCHET AN...

NexxZr™ / W-98-18-UT-A300-ML

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271138453·

Orthoquest

FDA UDI
Young Innovations, Inc.·00843471134214·Ss D-Form 021X025

HEARTWAY POWER CHAIR, P23

FDA 510(k)
FDA Class 2 ·Physical Medicine

MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123

FDA 510(k)
FDA Class 2 ·Anesthesiology

NA

FDA UDI
BICON, LLC·00813110024732·2.0mm Cotton Tip Applicator

NA

FDA UDI
aap Implantate AG·04042409049200·K-wire with thread and trocar point, ø3.0, L 270

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

NA

FDA UDI
aap Implantate AG·04042409049217·K-wire with thread and trocar point, ø3.0, L 270

FG GATEWAY OTW OUS 2.00MM X 15MM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MINN·Product code GBA·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 25, 2011

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA

FDA Recall
Terminated ·Rita Medical Systems, Inc.·Product code GEI·May 2, 2006

MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 16, 2016

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024