29 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ampa One System (AMPA-001)
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517302861·CoRoent XL-K Keel Cutter, 10mm Long
SALTI 3.5mm Medial Distal Tibia Plate, 14 Hole, Left
FDA UDI
Bonebridge AG·07640187462449·
GIBSON HEALTHCARE
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975012623·Collagen wound dressing, 2 cm x 4 cm x 3 mm
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246783032·Trial
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192329·Revision Knee Reamer Spiral Fluted - Zimmer 21mm
Sterile Auto-Disable Syringes with/without Needle for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
The Micro Screw System, Micro Screw System Basic
FDA 510(k)
FDA Class 2
·Dental
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
NA
FDA UDI
aap Implantate AG·04042409261268·Cortical Screw 2.5, small head T8, self-tapp. L 10
1.5MM CANN. QUICK RELEASE DRIVER TIP
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·June 14, 2024
1.5MM CANN. QUICK RELEASE DRIVER TIP
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·June 14, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HWC·June 14, 2024
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·May 28, 2025
UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code MOQ·November 14, 2014
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 12, 2011
2520274-2013-04657
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 29, 2013
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
FDA Enforcement
Class II
·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..
FDA Enforcement
Class II
·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026
TAPERLOC 133 FP TYPE1 PPS HO 5.0 T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·March 30, 2020