|
Device |
system, measurement, blood-pressure, non-invasive |
Product Code | DXN |
Regulation Number |
870.1130
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A & D CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
A&D COMPANY, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
A&D COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ACCUMED HEALTHCARE (SHANGHAI) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACCURATE MEDITECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADFLOW HEALTH NETWORKS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADON HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGELESS HEALTH INDUSTRIAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGELESS HEALTH INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AGUIFLAI IBERICA S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALICN MEDICAL (SHENZHEN), INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALICN MEDICAL SHENZHEN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALICN MEDICAL SHENZHEN,INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANDON HEALTH CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ANDON HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ANDON HEALTH CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
44
|
ANDON MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATCOR MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVITA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCARE ASIA CORPORATION LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLAND TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOSIGN TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSPACE CORPORATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BMEYE B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CALHEALTH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOCOM LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREMATIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARETAKER MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARETAKER MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CITIZEN SYSTEMS JAPAN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CNOGA MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CNSYSTEMS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COMPUTERIZED SCREENING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONMO ELECTRONIC COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTEC MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONTEC MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DATASCOPE CORP., PATIENT MONITORING DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN E-TEST TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DRAEGER MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFE SCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
EDWARDS LIFESCIENCES, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENGAGEMENTHEALTH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FAMIDOC TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FINAPRES MEDICAL SYSTEMS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FINAPRES MEDICAL SYSTEMS BV |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FORA CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUDAKANG INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUKUDA DENSHI USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUTREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENEXEL MEDICAL INSTRUMENT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL INSTRUMENTATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GMC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
21
|
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG GENIAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
H4D SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARVARD MEDICAL DEVICES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALTH & LIFE CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALTH & LIFE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALTH & LIFE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
19
|
HEALTH & LIFE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEALTHCHEK NETWORK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHSTATS INTERNATIONAL PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHSTATS INTERNATIONAL PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HETAIDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIGI SH LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HONSUN (NANTONG) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONSUN (NANTONG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HONSUN(NANTONG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HONSUN(NANTONG)CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOSMAN INTERNATIONAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I.E.M. GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IDT TECHNOLOGY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INBODY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INBODY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JAWON MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU YUYUE MEDICAL EQUIPMENT& SUPPLY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JINXINBAO ELECTRONIC CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JOYTECH HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K-JUMP HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LD TECHNOLOGY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIVEMETRIC (MEDICAL) S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LOTUSNINE MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIANA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIANA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDITECH LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC CARE MANAGEMENT SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROLIFE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROLIFE INTELLECTUAL PROPERTY GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
26
|
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MORTARA INSTRUMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOWEAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIHON SEIMITSU SOKKI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NINGBO DIAIER ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMRON HEALTHCARE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMRON HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
17
|
OSTAR MEDITECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PADTEST, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAR MEDIZINTECHNIK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PULSECOR LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PURSUANT HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PYRAMES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QARDIO INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QARDIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO YASEE MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RGB MEDICAL DEVICES SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROBERT BOSCH HEALTHCARE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RUDOLF RIESTER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SECA GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEERS TECHNOLOGY CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SHANGHAI LITTLE DOCTOR CO. LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKUN TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN COMBEI TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN FINICARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JAMR TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN JAMR TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIACOM TECHNOLOGY CO ., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIACOM TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN PANGO ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN PANGO ELECTRONIC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN URION TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN URION TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN VIATOM TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN YOLANDA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YOLANDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKANRAY TECHNOLOGIES PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKY INNOVATION TECHNOLOGY ( SHANGHAI) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLOHEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STAYHEALTHY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMMIT DOPPLER SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNTECH MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNTECH MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUZHOU SUNSPIRI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU SUNSPIRIT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
TAIWAN SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TENSYS MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERMOR LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRULY INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TRULY INSTRUMENT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRULY INSTRUMENT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYTAN MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES GTM MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISIOMED GROUP SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITA-COURSE TECHNOLOGIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WATERMARK MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELCH ALLYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WENZHOU BOKANG INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZHOU YOSUN MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEONY (SHENZHEN) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WISTRON CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WITHINGS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XIAMEN ANTS BRO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
YA HORNG ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZOE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
A & D Enginering Inc |
II |
Oct-09-2016 |
2 |
Baxter Healthcare Corporation |
II |
Apr-10-2024 |
3 |
Del Mar Reynolds Medical, Ltd. |
II |
Nov-29-2011 |
4 |
Edwards Lifesciences, LLC |
I |
May-21-2019 |
5 |
Edwards Lifesciences, LLC |
II |
Jun-09-2015 |
6 |
FMS, Finapres Medical Systems BV |
II |
Aug-06-2012 |
7 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Apr-01-2024 |
8 |
Mediana Co., Ltd. |
II |
Jul-19-2021 |
9 |
Mediana Co., Ltd. |
II |
Jun-26-2020 |
10 |
Mindray DS USA, Inc., dba Datascope Patient Monitoring |
II |
Apr-15-2010 |
11 |
Philips Healthcare Inc. |
II |
Feb-14-2013 |
12 |
Philips Healthcare Inc. |
II |
Aug-30-2012 |
13 |
Physio Control, Inc. |
II |
Sep-18-2009 |
14 |
Suntech Medical, Inc. |
II |
Jun-25-2020 |
15 |
Suntech Medical, Inc. |
II |
Jan-14-2020 |
16 |
Welch Allyn Inc |
II |
May-21-2021 |
17 |
Welch Allyn Inc |
II |
Apr-11-2017 |
18 |
Withings Sas |
II |
Aug-16-2018 |
19 |
Zoe Medical Incorporated |
II |
Aug-03-2010 |
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