Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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STANDARD AME
Avalign Technologies, Inc.
63-745001A
In Commercial Distribution

  • 00190776194406 ()


  • Hand-held surgical retractor, reusable
CUSTOM PACK 7S49R2 4PK VAC APK
MEDTRONIC, INC.
7S49R2
In Commercial Distribution

  • 20643169613366 ()
  • 00643169613355 ()


  • Cardiopulmonary bypass system blood tubing set
Charley Retractor Narrow ame
Avalign Technologies, Inc.
63-744501B
In Commercial Distribution

  • 00190776192716 ()


  • Hand-held surgical retractor, reusable
Weler Standard Octagon ame
Avalign Technologies, Inc.
63-485205
In Commercial Distribution

  • 00190776192457 ()


  • Self-retaining surgical retractor, reusable
Vision Retractor ame post
Avalign Technologies, Inc.
72-184020
In Commercial Distribution

  • 00190776206352 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
CLIMATELINEAIR 11 OXY - AME
RESMED PTY LTD
39232
In Commercial Distribution

  • 00619498392322 ()


  • Ventilator breathing circuit, reusable
CHARNLEY STANDARD RETR AME ONLY
Avalign Technologies, Inc.
63-744501
In Commercial Distribution

  • 00190776191887 ()


  • Hand-held surgical retractor, reusable
INITIAL INCISION RETR AME ONLY
Avalign Technologies, Inc.
63-52704F
In Commercial Distribution

  • 00190776191825 ()


  • Hand-held surgical retractor, reusable
CHARNLEY STANDARD RETR AME and BLADES
Avalign Technologies, Inc.
63-7445
In Commercial Distribution

  • 00190776191733 ()


  • Hand-held surgical retractor, reusable
O'Connor Sternum ame Only angled arms
Avalign Technologies, Inc.
63-7404600
In Commercial Distribution

  • 00190776189976 ()


  • Surgical retraction system, reusable
Assistant ee Blade for Charnley for ame
Avalign Technologies, Inc.
63-745506
In Commercial Distribution

  • 00190776189914 ()


  • Surgical retraction system, reusable
SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable
SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable
Weler Large ame lateral catches for four blades
Avalign Technologies, Inc.
63-485204
In Commercial Distribution

  • 00190776192402 ()


  • Self-retaining surgical retractor, reusable
O'Connor O'Sullivan Retractor ame Only fied lateral blades deep
Avalign Technologies, Inc.
63-G5560F12
In Commercial Distribution

  • 00190776193195 ()


  • Hand-held surgical retractor, reusable
Knot pusher for placing knots for laparoscopic surgery. The various Knotpushers are intended for ligature passing and knot tying.
AMI Agency for Medical Innovations GmbH
APK 001
Not in Commercial Distribution

  • EAMIAPK0010 ()
APK 001

  • Suture knot pusher, reusable
SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable
M-Tech Compatible Disposable Infant SpO2 Sensor
APK Technology Co.,Ltd.
MAS-2319
In Commercial Distribution

  • 06946725538814 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible Datex Ohmeda Reusable Adult Ear Clip SpO2 Sensor
APK Technology Co.,Ltd.
10274
In Commercial Distribution

  • 06946725540879 ()


  • Tissue saturation oximeter sensor, reprocessed
Mindray Compatible SpO2 Sensor, 9 Foot Cable: Adult Clip
APK Technology Co.,Ltd.
S410-62D0
In Commercial Distribution

  • 06946725540862 ()


  • Tissue saturation oximeter sensor, reprocessed
Datascope Compatible Trio Compatible Oximax Direct Connect Multi-Site Sensor
APK Technology Co.,Ltd.
10305
In Commercial Distribution

  • 06946725540855 ()


  • Tissue saturation oximeter sensor, reprocessed
M-tech Compatible Pediatric Clip SpO2 Sensor
APK Technology Co.,Ltd.
MAS-1864
In Commercial Distribution

  • 06946725540848 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible LNCS (2320, 2329) Neonatal/Adult Disposable SpO2 Sensor
APK Technology Co.,Ltd.
Mas-2329-NC
In Commercial Distribution

  • 06946725540831 ()


  • Tissue saturation oximeter sensor, reprocessed
Meditech Compatible SpO2 Sensor, 9 Foot Cable: Adult Sof
APK Technology Co.,Ltd.
S410S-65D0
In Commercial Distribution

  • 06946725540770 ()


  • Tissue saturation oximeter sensor, reprocessed
BCI compatible sensor, 3 foot cable: Pediatric clip
APK Technology Co.,Ltd.
S103-060
In Commercial Distribution

  • 06946725540756 ()


  • Tissue saturation oximeter sensor, reprocessed
Nonin Compatible Disposable Sensors Infant 6000CI/7000I
APK Technology Co.,Ltd.
S533-080
In Commercial Distribution

  • 16946725591564 ()
  • 06946725540749 ()


  • Tissue saturation oximeter sensor, reprocessed
Disposable MX40 leadwire with SPO2 extension cable samples
APK Technology Co.,Ltd.
A0003D05-003
In Commercial Distribution

  • 06946725540725 ()


  • Electrocardiographic lead set, reusable
Ohmeda Compatible OXY-F4-H SpO2 Sensor: Neonate Soft
APK Technology Co.,Ltd.
S310-020
In Commercial Distribution

  • 06946725540718 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible DRE Waveline SpO2 Sensor, Adult Clip
APK Technology Co.,Ltd.
S410-2130
In Commercial Distribution

  • 06946725540657 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible Risingmed RPM 900A SpO2 Adult Clip Sensor
APK Technology Co.,Ltd.
S410-1750
In Commercial Distribution

  • 06946725540633 ()


  • Tissue saturation oximeter sensor, reprocessed
Nonin Compatible Adult Ear Clip Sensor Connector with 7 Pins
APK Technology Co.,Ltd.
S903-08T0
In Commercial Distribution

  • 06946725540626 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible Pace Tech SpO2 Sensor, 6 Pins, Touch-Screen models Neonate
APK Technology Co.,Ltd.
S310-960
In Commercial Distribution

  • 06946725540619 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible Risingmed RPM 900A SpO2 Adult Clip Sensor
APK Technology Co.,Ltd.
S410-1750
In Commercial Distribution

  • 06946725540602 ()


  • Tissue saturation oximeter sensor, reprocessed
GE Marquette Compatible Disposable ECG Lead Set Clip/Grabber
APK Technology Co.,Ltd.
LQ5-90DP0
In Commercial Distribution

  • 06946725540473 ()


  • Electrocardiographic lead set, reusable
Nellcor compatible sensor, 3 foot cable: Adult soft
APK Technology Co.,Ltd.
S403S-010
In Commercial Distribution

  • 06946725540404 ()


  • Tissue saturation oximeter sensor, reprocessed
Edan Compatible Adult Clip Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A1202-SA164PV
In Commercial Distribution

  • 06946725540398 ()


  • Tissue saturation oximeter sensor, reprocessed
Criticare Compatible Adult Ear Clip SpO2 Sensor
APK Technology Co.,Ltd.
S903-750
In Commercial Distribution

  • 06946725540367 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible GE TruSignal TS-F-D SpO2 Sensor: Adult Soft
APK Technology Co.,Ltd.
S403S-1170
In Commercial Distribution

  • 06946725540299 ()


  • Tissue saturation oximeter sensor, reprocessed
Comen Compatible Direct-Connect Adult Clip
APK Technology Co.,Ltd.
S410-208D0
In Commercial Distribution

  • 06946725538906 ()


  • Tissue saturation oximeter sensor, reprocessed
Direct Connect Nonin Compatible SpO2 Sensor, 9 Foot Cable: Pediatric Soft
APK Technology Co.,Ltd.
S110S-08L0
In Commercial Distribution

  • 06946725538890 ()


  • Tissue saturation oximeter sensor, reprocessed
Meditech Compatible SpO2 Sensor, 9 Foot Cable: Neonate Soft
APK Technology Co.,Ltd.
S310-65D0
In Commercial Distribution

  • 06946725538883 ()


  • Tissue saturation oximeter sensor, reprocessed
Masimo Compatible SpO2 Sensor DC-8 2387: Neonate Soft
APK Technology Co.,Ltd.
S310-150
In Commercial Distribution

  • 06946725538876 ()


  • Tissue saturation oximeter sensor, reprocessed
M-Tech Compatible Disposable Pediatric SpO2 Sensor
APK Technology Co.,Ltd.
MAS-LNCS Pdtx
In Commercial Distribution

  • 06946725538807 ()


  • Tissue saturation oximeter sensor, reprocessed
Direct Connect Nellcor Compatible OxiMax SpO2 Sensor: Multi Site Sensor
APK Technology Co.,Ltd.
S810-70P0
In Commercial Distribution

  • 06946725538784 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor compatible sensor, 3 foot cable: Neonate soft
APK Technology Co.,Ltd.
S303-010
In Commercial Distribution

  • 06946725538760 ()


  • Tissue saturation oximeter sensor, reprocessed
Nellcor compatible sensor, 3 foot cable: Pediatric soft
APK Technology Co.,Ltd.
S103S-010
In Commercial Distribution

  • 06946725538753 ()


  • Tissue saturation oximeter sensor, reprocessed
Masimo Compatible Disposable Adult SpO2 Sensor
APK Technology Co.,Ltd.
MAS-LNCS Adtx
In Commercial Distribution

  • 06946725538722 ()


  • Tissue saturation oximeter sensor, reprocessed
Masimo Compatible Neonatal/Adult Disposable SpO2 Sensor
APK Technology Co.,Ltd.
MAS-2329
In Commercial Distribution

  • 06946725538708 ()


  • Tissue saturation oximeter sensor, reprocessed
Reusable SpO2 Sensors
APK Technology Co.,Ltd.
A0816-SA206PU
In Commercial Distribution

  • 06946725538630 ()


  • Tissue saturation oximeter sensor, reprocessed
Reusable SpO2 Sensor Wrapping
APK Technology Co.,Ltd.
S805-160
In Commercial Distribution

  • 06946725538586 ()


  • Pulse Co-oximeter probe, reusable
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