21 results · 20ms · Sources: EU EUDAMED, US FDA

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AMSCO CHIMERON SMALL STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III

n/a

FDA UDI
Ortho Development Corporation·00822409076086·Femoral Broach/Trial 1223

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450159941·

Vatech Clismile

FDA UDI
Rayence Co., Ltd.·08800018600979·This product is an orthodontic bracket and is u...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089445516·

Rumex

FDA UDI
RUMEX INTERNATIONAL CORP.·00840159905043·Barraquer Iris Scissors, Blunt Tips, 8.00 mm Fr...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve

iGUIDE

FDA UDI
3C-Medical Intelligence GmbH·04056719002190·iGUIDE is the control software of the HexaPOD™ ...

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089451128·

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA

FDA 510(k)
FDA Class 2 ·Ophthalmic

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·January 23, 2017

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 1, 2015

MEDI-LIFT

FDA Adverse Event
Injury ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·April 19, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·May 12, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

BD PYXIS¿ ANESTHESIA STATION ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024