19 results
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29ms
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Sources: EU EUDAMED, US FDA
HEMA - NV TRANS. BLOOD FILTER 100/800
FDA 510(k)
FDA Class 2
·General Hospital
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556838808·3.5mm plate locking screw 14mm
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780118404·The locking rearfoot screw is used in the Integ...
Masel
FDA UDI
Ortho Organizers, Inc.·00190707034580·.014 Lower Value Brand Of Niti Natural Form Arc...
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310830014CFG1·NTI Diamond Coarse FG
Persona®
FDA UDI
Zimmer, Inc.·00889024551138·
Persona®
FDA UDI
Zimmer, Inc.·00889024551145·
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·CORAB-M
A1C GEAR SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ATAC TOTAL BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAXCUT DIAMOND BURS (6/pk) CRS 6830-014
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006830141·MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (i...
MAXCUT DIAMOND BURS (6/pk) MED 830-014
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100830141·MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (i...
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 23, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012
MAXIMO DR
FDA Adverse Event
Death
·MEDTRONIC S.A.·Product code LWS·September 10, 2010
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·February 5, 2020
TI POLYAXIAL HEAD FOR USS POLYAXIAL
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·May 14, 2019
TI POLYAXIAL HEAD FOR USS POLYAXIAL
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·May 14, 2019
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Recall
Terminated
·ROi CPS LLC·Product code LRO·January 3, 2020