61 results · 23ms · Sources: EU EUDAMED, US FDA

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InFill Interbody Fusion Devices

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120571·Guidewire 2.0x150mm Sgl Trocar

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120564·Guidewire 2.0x150mm Dbl Trocar

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100097·BARRAQUER SPECULUM SOLID SMALL

CEDIA TACROLIMUS ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AESCULAP- MEITHKE SHUNT SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

IMPELLA CP

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·January 7, 2026

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 27, 2016

UNK_INTRODUCER

FDA Adverse Event
Malfunction ·ABIOMED, INC. - 1220648·Product code DYB·February 6, 2026

OMNIPOD 5 POD

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·July 13, 2022

LAKE REGION 0.027" PTFE GUIDEWIRE

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·January 14, 2026

Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 28, 2013

GOBED+

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·June 10, 2011

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

FDA Adverse Event
Injury ·COSTA RICA·Product code LTI·September 3, 2008

MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·February 9, 2022