17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EmboCube Embolization Gelatin
FDA 510(k)
FDA Class 2
·Cardiovascular
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270855·
Epredia
FDA UDI
SHANDON DIAGNOSTICS LIMITED·05051663517850·STP120 Tissue Processor - Accessory
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042123380·1000 Stainless Steel Ligature Ties - .012
SILICONE MAT
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019331·SILICONE MAT WITH HOLES
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027817·Jansen Mastoid Ret, 4x4 prngs, blnt, 4 1/2"
CHF-Y0005
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORIN BIOLOX DELTA FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 14, 2019
RADIOLUCENT-DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 17, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 21, 2013
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIM·July 28, 2011
ALARIS SYSTEM
FDA Adverse Event
Death
·CAREFUSION SD·Product code FRN·November 9, 2021
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·January 4, 2017
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 8, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024