51 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Phantom® Hindfoot TTC/TC Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007417·1420A SERIES SUB-ASSY/LESS MPC
10PW - Penn Power & Light
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012179·10PW - Penn Power & Light
Drive Rail
FDA UDI
ORTHOPEDIATRICS CORP.·00817867020085·Arch, 27 cm
NAVIGATED INSTRUMENTS;PHOENIX SFS
FDA UDI
Orthofix US LLC·18257200119691·CANNULATED TAP, 7.5MM, PHOENIX NAVIGATED BL
ROSENBERG
FDA UDI
The Wells Johnson Company·B458201227000·Cannula, Rosenberg, specify length, diameter an...
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
FDA 510(k)
FDA Class 2
·Ophthalmic
ZOLL-DENTAL
FDA UDI
Zoll-Dental·00840105214731·A-Type SYR-201-227-02
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 1, 2005
SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·August 29, 2024
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code LWJ·March 22, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 17, 2012
WMT SLT TAPER COBALT-CHROME FEMORAL HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code LZO·March 22, 2017
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 20, 2008
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·July 29, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 2, 2013
ASR TAP SLV ADAP 11/13 +0
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·October 23, 2012
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·October 23, 2012