26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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