18 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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LATEX EXAMINATION GLOVES (POWDERED)
FDA 510(k)
FDA Class 1
·General Hospital
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031037·Basin Set
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450198346·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383554671·Gutta Percha Points is used to root canal filin...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018333·Wide Jaw Punch small 15 degree up milled 3.5mm ...
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
FDA 510(k)
FDA Class 2
·Cardiovascular
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 9, 2024
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 20, 2013
THE EMAX 2 PLUS SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code HBL·November 5, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022