578 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RenovoCath
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578488·CoRoent Ant TLIF Ti, 11x12x32mm 4°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV
NA
FDA UDI
Synthes GmbH·10886982152565·3.5MM CONICAL SCREW SLF-TPNG FULLY THREADED 60MM
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331137815·halsey needle holder, 5 3/8" (13.7 cm), serrate...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
Distal Ulna Plate
FDA UDI
I.T.S. GmbH·09120047296486·Distal Ulna Plate, 4-Hole, Left
CERALAS 980NM DIODE LASER FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK ACTIVE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FG 6301 DUAL CHNL VOL INF PUMP2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·December 19, 2022
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·January 2, 2025
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 30, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·July 17, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·May 26, 2022