ClearanceBrief
Panels › Cardiovascular › Product code DPW · Class 2

Flowmeter, Blood, Cardiovascular

Regulation 870.2100

3510(k)s in 12 months (138 all time)
1recalls in 12 months (35 all time)
31recalls that name a 510(k)
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Top companies in DPW

DateFirm and productCodeLinked 510(k)
Mar 24, 2026Koven Technology, Inc.
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Des
Open, Classified
DPWK954397
Oct 29, 2025Medistim Asa
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound devi
Open, Classified
DPWK102595
Sep 4, 2025Flosonics Medical (R/A 1929803 ONTARIO CORP.)
FloPatch FP120, REF: FP120-FOT01-005
Open, Classified
DPWK200337
K223843
Jul 20, 2023Baxter Healthcare Corporation
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Open, Classified
DPWK191252
Jun 19, 2018Vascular Technology, Inc.
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic
Terminated
DPWK031091
Apr 25, 2017Medistim Asa
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Terminated
DPWK040228
Apr 21, 2016Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to
Terminated
DPWK143589
Apr 21, 2016Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-
Terminated
DPWK132727
K143589
Apr 21, 2016Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to
Terminated
DPWK132727
Apr 21, 2016Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-t
Terminated
DPWK132727
Apr 21, 2016Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to
Terminated
DPWK132727
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Sep 3, 2015Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Terminated
DPWK872048
Jul 29, 2014Baxter Healthcare Corporation
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstr
Terminated
DPWK132727
Jul 7, 2014Vascular Technology, Inc.
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Terminated
DPWK082870
Jul 7, 2014Vascular Technology, Inc.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Terminated
DPWK082870
Jul 7, 2014Vascular Technology, Inc.
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Terminated
DPWK082870
Jul 7, 2014Vascular Technology, Inc.
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Terminated
DPWK082870
Dec 10, 2012Parks Medical Electronics, Inc
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessor
Terminated
DPWK944495
Oct 22, 2010Escalon Medical Corp
PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in g
Terminated
DPWK903625
Jul 3, 2008Parks Medical Electronics Inc
Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Terminated
DPWNone listed
Jul 3, 2008Parks Medical Electronics Inc
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Terminated
DPWNone listed
Jul 3, 2008Parks Medical Electronics Inc
Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Terminated
DPWNone listed
Jul 3, 2008Parks Medical Electronics Inc
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
Terminated
DPWNone listed
Jun 3, 2005Philips Ultrasound, Inc.
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)
Terminated
DPWK002186
Apr 13, 2005Neoprobe Corp
Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
Terminated
DPWK030357
Apr 13, 2005Neoprobe Corp
Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.
Terminated
DPWK030357

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