17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00410101·
LEONE SPA
FDA UDI
LEONE SPA·08033707002093·CHROMIUM-COBALT WIRE 1,0mm
PAQ.245X300X1000/EEG/041010
FDA UDI
AB MEDICA GROUP, S.A.·08428763006930·
i-ED COIL
FDA UDI
KANEKA CORPORATION·04540778177543·The i-ED COIL is used for vascular embolization...
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0110100·Awl, 10mm
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0110100·Sizer, Smooth, Ratcheting
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0110100·Sounder, Ball Tip, Straight, Firm
ASCENT KNEE REVISION FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HATCP STEM POR TIB PLT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 5, 2024
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 8, 2013
LAMITRODE 44 SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 25, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·August 27, 2014
BD PEGASUS 20 G X 1.16 IN
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·December 15, 2015
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018