578 results · 26ms · Sources: EU EUDAMED, 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