BEUDAMED
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    Filters Classification: Class Ii ×

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Enforcement
    Class II ·Ongoing·Withings·March 29, 2023

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Enforcement
    Class II ·Completed·Withings Sas·August 22, 2018

    MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 20, 2019

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0479-01C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0479-02C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0479-07 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0479-08 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) D684-00-0479-09 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0479-10 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0479-01U LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0479-02U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0480-01 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0480-02 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0480-01C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0480-02C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0480-07 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) D684-00-0480-08 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0480-09 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0480-10 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0480-01U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0480-02U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES D684-00-0478-01 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) D684-00-0478-02 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) D684-00-0478-01C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) D684-00-0478-02C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) D684-00-0478-07 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0478-08 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) D684-00-0478-09 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0478-10 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY D684-00-0478-01U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY D684-00-0478-02U PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs D884-00-0019-12 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs D884-00-0019-13

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reorder #310CRK, Sterile; (7) Centurion CirClamp with 1.3cm Bell, Reorder #330CR, Sterile; (8) Centurion CirClamp with 1.3cm Bell Reprocessed, Reorder #330CRK, Sterile; (9) Centurion CirClamp with 1.6cm Bell, Reorder #345CR, Sterile; (10) Centurion CirClamp with 1.45cm Bell, Reorder #3145CR, Sterile; (11) Centurion CirClamp with 1.1cm Bell & Insert Reprocessed, Reorder #CR210K, Sterile; (12) Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile; (13) Centurion CirClamp with 1.145cm Bell & Insert Reprocessed, Reorder #CR245K, Sterile; (14) Centurion CirClamp with 1.6cm Bell Reprocessed, Reorder #CR345K, Sterile; and (15) Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder #CR3145K.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024

    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0295-03 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0295-05 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0295-06 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0295-07 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA D684-00-0295-08 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0295-09 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0295-10 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0295-01U MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0295-02U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES D684-00-0294-01 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) D684-00-0294-02 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0294-03 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) D684-00-0294-05 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0294-06 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0294-07 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA D684-00-0294-08 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) D684-00-0294-09 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0294-10 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY D684-00-0294-01U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0294-02U PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs D884-00-0019-21

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·March 25, 2015

    Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·April 22, 2015

    Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

    FDA Enforcement
    Class II ·Ongoing·Mozarc Medical US LLC·June 17, 2026

    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 24, 2026

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    FDA Enforcement
    Class II ·Ongoing·Western/Scott Fetzer Company·April 19, 2023

    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·April 23, 2014

    SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0576-09 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0576-01U PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB D884-00-0019-23

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 25, 2024

    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0470-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0470-09 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES D684-00-0470-01 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0470-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0469-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES D684-00-0469-01 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY D684-00-0469-09 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs D884-00-0019-16

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023