34 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300744·
NA
FDA UDI
MAKO SURGICAL CORP.·00848486001322·BONE PINS (4MM X 170MM)
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052429·1.6mm Twist Drill, 4mm STOP, Hex Shank
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026438·microSelectron Transfer Tube for 6F Flexibles (30)
DONJOY
FDA UDI
DJO, LLC·00888912218146·ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873097999·2.4mm Locking Volar Distal Radius Plate, 4 Hole...
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 8, 2017
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 13, 2008
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 10, 2017
3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 15, 2017
OSS NON-MOD TIB PLATE LONG 71 LONG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 15, 2021
OSS CEMENTED IM STEM 17X150 50
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 15, 2021
OSS 3CM RESURF FEMORAL LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 15, 2021
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013