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
Vision Retractor ame post
Avalign Technologies, Inc.
72-184020
In Commercial Distribution

  • 00190776206352 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
Weler Standard Octagon ame
Avalign Technologies, Inc.
63-485205
In Commercial Distribution

  • 00190776192457 ()


  • Self-retaining surgical retractor, reusable
Charley Retractor Narrow ame
Avalign Technologies, Inc.
63-744501B
In Commercial Distribution

  • 00190776192716 ()


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

  • 00190776189976 ()


  • Surgical retraction system, reusable
CHARNLEY STANDARD RETR AME and BLADES
Avalign Technologies, Inc.
63-7445
In Commercial Distribution

  • 00190776191733 ()


  • Hand-held surgical retractor, 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
Kit Contains: CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK298
In Commercial Distribution

  • 20607915136554 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK258
In Commercial Distribution

  • 20607915134864 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK221
In Commercial Distribution

  • 20607915129877 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CTF33, 11x100 Kii Fios ZTHR 6/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK213
In Commercial Distribution

  • 20607915129402 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK212
In Commercial Distribution

  • 20607915129396 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
M-Tech Compatible Disposable Infant SpO2 Sensor
APK Technology Co.,Ltd.
MAS-2319
In Commercial Distribution

  • 06946725538814 ()


  • Tissue saturation oximeter sensor, reprocessed
Nonin Compatible Infant finger soft , DB9(7pin) Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A1414-SI103PU
In Commercial Distribution

  • 06946725539507 ()


  • Pulse Co-oximeter probe, reusable
Nellcor Compatible Reusable SpO2 Sensor, Pediatric Finger Clip
APK Technology Co.,Ltd.
A1418-SP103MV
In Commercial Distribution

  • 06946725538715 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1414-SA103PV
In Commercial Distribution

  • 06946725538036 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1414-SA103PU
In Commercial Distribution

  • 06946725538029 ()


  • Pulse Co-oximeter probe, reusable
Masimo Compatible, Adult Finger Clip, 1.0M
APK Technology Co.,Ltd.
S403-490
In Commercial Distribution

  • 06946725530283 ()


  • Pulse Co-oximeter probe, reusable
Compatible Newtech NT2A SpO2 Sensor, 9 Foot Cable: Adult Soft
APK Technology Co.,Ltd.
S410S-165D0
In Commercial Distribution

  • 06946725579664 ()


  • Pulse Co-oximeter probe, reusable
SpO2 Adult Ear Clip Attachment
APK Technology Co.,Ltd.
10841
In Commercial Distribution

  • 06946725579480 ()


  • Electrocardiographic lead set, reusable
Compatible Datex Ohmeda Reusable Adult Soft SpO2 Sensor
APK Technology Co.,Ltd.
10269
In Commercial Distribution

  • 06946725579473 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible SpO2 Sensor, 9 Foot Cable: Pediatric Soft
APK Technology Co.,Ltd.
S110S-080
In Commercial Distribution

  • 06946725579466 ()


  • Pulse Co-oximeter probe, reusable
CUSTOM Compatible Nellcor Oximax SpO2 Sensor, Adult Clip, 20 ft
APK Technology Co.,Ltd.
S460-70P0
In Commercial Distribution

  • 06946725579459 ()


  • Pulse Co-oximeter probe, reusable
Nellcor Compatible SpO2 Sensor, 9 Foot Cable: Adult Soft
APK Technology Co.,Ltd.
S410S-010
In Commercial Distribution

  • 06946725579428 ()


  • Pulse Co-oximeter probe, reusable
Direct Connect Edan Compatible SpO2 Sensor Pediatric Clip
APK Technology Co.,Ltd.
S110-191P0
In Commercial Distribution

  • 06946725579312 ()


  • Pulse Co-oximeter probe, reusable
Direct Connect Nonin Compatible SpO2 Sensor
APK Technology Co.,Ltd.
S310-08L0
In Commercial Distribution

  • 06946725579275 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor, Adult Soft
APK Technology Co.,Ltd.
S410S-070
In Commercial Distribution

  • 06946725554401 ()


  • Pulse Co-oximeter probe, reusable
Masimo Compatible SpO2 Sensor LNOP DCSC 1396, 3 Foot Cable
APK Technology Co.,Ltd.
S403-150
In Commercial Distribution

  • 06946725554395 ()


  • Tissue saturation oximeter sensor, reprocessed
CUSTOM Length Criticare SpO2 Sensor, 20 ft, Adult Clip
APK Technology Co.,Ltd.
10470
In Commercial Distribution

  • 06946725554364 ()


  • Tissue saturation oximeter sensor, reprocessed
Disposable Neonate Adult GE OxyTip Sensos
APK Technology Co.,Ltd.
S543-1270
In Commercial Distribution

  • 16946725597689 ()
  • 06946725554340 ()


  • Tissue saturation oximeter sensor, reprocessed
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