41 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
XIOS+
FDA UDI
SIRONA DENTAL, INC.·D76462017551·SIRONA XIOS PLUS SENSOR SIZE 1 SHIP KIT
HHM
FDA UDI
Oticon A/S·05707131351579·G500 SC, BTE PP 13 2.4G 105 C048 TAR HHM
METAPHYSARY BROACH ESOP LEFT SIZE 7,5
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017551·
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136022536·7450XS FACE MASK-HDGR& 2600 MA
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063327·TI ILIAC BONE SCREW ASSY, 8.5MM X 55MM X 15°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063334·Ti ILIAC BONE SCREW ASSY, 8.5mm X 55mm X 30°
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX MEDICAL DIGITAL TENS TS1211, TS1212
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·March 24, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 26, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 5, 2011
BD¿ BLUNT FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·October 31, 2018
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025