21 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
FDA 510(k)
FDA Class 2
·Anesthesiology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950023325·CANNULA IRRIGATION 14GX3" 45 DEGREE
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074010236·INSTRUMENT 2900164 REAMER T HANDLE
NA
FDA UDI
Smith & Nephew, Inc.·00885554008036·SOD OBT CONICAL FOR6900163
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMR REVERSE HUMERAL BODY
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·October 21, 2022
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 28, 2014
UNKNOWN STRATA VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·October 22, 2010
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 7, 2013
H-MAX S LATERALIZED FEMORAL STEM #8
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MEH·March 23, 2023
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·October 8, 2014
Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
FDA Enforcement
Class II
·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014