25 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS
Xltek
FDA UDI
XLTEK·00382830046244·P32 ACQ POD 1 - 1'
NA
FDA UDI
Synthes GmbH·10887587038995·1.8MM TROCAR DRILL BIT/QC 100MM/18MM CALIBRATION
3M™ Unitek™ Victory Series™ MBT™
FDA UDI
3m do Brasil Ltda.·00652221011503·Victory Series(TM) Bracket MBT(TM) UR2 10T/8A ....
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837039288·OCT Plate Bender
FDA Pre-Market Approval
INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 11, 2025
TENDRIL SDX LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·May 11, 2021
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 9, 2015
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 2, 1999
ACE BRAND INSTANT COLD COMPRESS
FDA Adverse Event
Injury
·BECTON DICKINSON CONSUMER PRODUCTS·Product code IME·September 4, 1997
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDO·February 26, 2001
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 17, 2012
UNKNOWN SALINE IMPLANTS
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·August 26, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 3, 2015
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 29, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 28, 2012
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Impella RP with SmartAssist; Product Number: 0046-0035;
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·January 22, 2025