21 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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