19 results · 28ms · Sources: EU EUDAMED, US FDA

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ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964023147·The ENDO CARRY-ON Procedure Kit contains all of...

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105633·PowerChem Neoprene Exam Gloves, Medium

4.0 X 34mm CANN SCREW FASTENER Ti FL THD

FDA UDI
Osteocentric Technologies, Inc.·00810074304726·4.0 X 34mm CANN SCREW FASTENER Ti FL THD

WVSM Wireless Vital Signs Monitor

FDA UDI
ATHENA GTX, INC.·B3945000034030·Wireless Patient Monitor

Spacelabs Healthcare

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124785·4 ELECTRODE EVO RECORDER PACKED, FRENCH

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVOFINE 31 DISPOSABLE NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

2.0X9MM FOSSA X-DR SCREW

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·January 28, 2016

2.7X10MM HT X-DRIVE SCREW

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·January 28, 2016

6.0MM TI MATRIX SCREW

FDA Adverse Event
Malfunction ·SYNTHES (USA) BRANDYWINE·Product code NKB·February 28, 2013

SYNCHRON UNICEL DXC 600

FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·March 1, 2011

UNICEL DXI 800 ACCESS IMMUNOASSSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 21, 2008

TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 5, 2015

TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 5, 2015

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024