24 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·July 1, 2015
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
FDA Enforcement
Class II
·Ongoing·Zeltiq Aesthetics, Inc·July 20, 2022
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 16, 2019
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·November 6, 2024
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
FDA Enforcement
Class II
·Terminated·Salyer Prn Biomedical·March 13, 2013
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·August 28, 2019
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·April 26, 2023
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·July 12, 2023
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
FDA Enforcement
Class II
·Terminated·Pro-Med Instruments Gmbh·December 13, 2017
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
FDA Enforcement
Class II
·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.
FDA Enforcement
Class II
·Ongoing·Medline Industries, Inc.·July 24, 2019
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012