23 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089409464·
COMPEX
FDA UDI
DJO, LLC·00190446287063·COMPEX TENS/HEAT KNEE WRAP KIT L/XL
COMPEX
FDA UDI
DJO, LLC·00190446287056·COMPEX TENS/HEAT KNEE WRAP KIT S/M
Table Cutters
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068868·
CYTOFLEX
FDA 510(k)
FDA Class 2
·Dental
CANDELA GENTLELASE FAMILY OF LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 7, 2002
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873106288·3.5mm Locking Distal Fibula Plate, 7 Holes, Right
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 17, 2019
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 25, 2002
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·January 18, 2017
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·August 6, 2008
TURBO-JECT POWER INJECTABLE
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·July 3, 2018
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 29, 2018
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2017
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020