21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct
FDA UDI
ARISE MEDICAL LLC·00372217007036·Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct
Holder, Needle, TC, acc. Lemmon 17cm
FDA UDI
Geister Medizintechnik GmbH·04057034066324·Holder, Needle, TC, acc. Lemmon
17cm ...
EXEL HYPO NDL 23GX3/4"
FDA Adverse Event
Malfunction
·EXELINT INTERNATIONAL, CO.·Product code FMF·February 6, 2026
n/a
FDA UDI
Ortho Development Corporation·00822409070794·Snap-on Fem Augment Trial 4mm Posteriol Size 4
LANX ANTERIOR CERVIAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Apogee
FDA 510(k)
FDA Class 2
·Anesthesiology
ONE TOUCH II
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 10, 2002
OSSEOTITE® CERTAIN® IMPLANT 4 X 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 3, 2026
AMS 700 MS PUMP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCW·April 6, 2026
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·October 30, 2014
4MM FLUTED BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
EXEL IV CATH 22GX1"
FDA Adverse Event
Malfunction
·EXELINT INTERNATIONAL, CO.·Product code FOZ·October 30, 2025
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.
FDA Enforcement
Class II
·Terminated·Pajunk Medical Systems, L.P.·November 30, 2022
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020