| K170514 |
02/21/2017 |
Central Monitoring System |
Guangdong Biolight Meditech Co., Ltd. |
| K151287 |
05/14/2015 |
Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
| K153135 |
10/30/2015 |
VITAL SIGNS MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
| K153580 |
12/15/2015 |
Central Monitoring System |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
| K210381 |
02/09/2021 |
I.V. Administration Set |
BQ PLUS Medical Co., Ltd. |
| K242126 |
07/19/2024 |
I.V. Administration Set |
BQ Plus medical Co.,Ltd. |
| K223645 |
12/06/2022 |
I.V. Administration Set, I.V. Extension Set |
BQ PLUS Medical Co., Ltd |
| K182286 |
08/23/2018 |
Oh'Care Lite Smart Blood Glucose Monitoring System |
OSANG Healthcare Co., Ltd. |
| K142290 |
08/18/2014 |
KangLi pedical screw spinal system |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K250360 |
02/10/2025 |
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) |
Shenzhen Jiantuo Electronics Co., Ltd. |
| K212137 |
07/08/2021 |
X-Clever |
LG Electronics.Inc |
| K220532 |
02/24/2022 |
Disposable surgical mask |
Xiamen Blue Star Enterprise Co., Ltd. |
| K230456 |
02/21/2023 |
SGM Femoral Nail System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K222031 |
07/11/2022 |
Spinal Inner Fixation System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K232394 |
08/09/2023 |
Internal Locking Plate and Screw Fixation System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K223776 |
12/16/2022 |
PEEK Spinal Infusion Cage |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K162234 |
08/09/2016 |
Truscope Ultra Patient Monitor |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
| K152739 |
09/23/2015 |
Electronic Thermometer |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
| K250913 |
03/27/2025 |
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System |
Jiangsu Tingsn Technology Co., Ltd. |
| K160341 |
02/08/2016 |
Colposcope System |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD |
| K250465 |
02/18/2025 |
CO2 Laser Machine (Lume) |
Nanjing Bestview Laser S&T Co., Ltd. |
| K200971 |
04/13/2020 |
308nm Excimer System |
Xuzhou Kernel Medical Equipment Co., Ltd. |
| K181805 |
07/06/2018 |
UV Phototherapy |
Xuzhou Kernel Medical Equipment Co., LTD. |
| K242440 |
08/16/2024 |
Intense Pulsed Light Treatment System (LK-PT) |
Nanjing Bestview Laser S&T Co., Ltd. |
| K212726 |
08/27/2021 |
Disposable Medical Surgical Mask |
Hubei Huaqiang High-Tech Co., Ltd. |
| K010099 |
01/11/2001 |
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER |
ZCV ,INC. |
| K960635 |
02/14/1996 |
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K970734 |
02/28/1997 |
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| DEN050003 |
02/28/2005 |
PAXGENE BLOOD RNA SYSTEM |
PREANALYTIX GMBH |
| K971054 |
03/24/1997 |
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K041071 |
04/26/2004 |
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 |
BECTON DICKINSON & CO. |
| K971717 |
05/09/1997 |
FLY THROUGH |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K011847 |
06/13/2001 |
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE |
ZYNERGY CARDIO VASULAR (ZCV), INC. |
| K022130 |
07/01/2002 |
BD VACUTAINER PLUS PST II TUBE |
BECTON DICKINSON & CO. |
| K241975 |
07/05/2024 |
SERV MEDICAL CDSS |
Serv Medical Pte. Ltd |
| K002481 |
08/14/2000 |
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 |
ZCV ,INC. |
| K002603 |
08/22/2000 |
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER |
ZCV ,INC. |
| K152415 |
08/26/2015 |
Digital Blood Pressure Monitor |
SUZHOU SUNSPIRIT CO., LTD. |
| K992885 |
08/27/1999 |
VERSALOK LOW BACK FIXATION SYSTEM |
OSTEOTECH, INC. |
| K002687 |
08/29/2000 |
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 |
ZYNERGY CARDIOVASCULAR, INC. |
| K023075 |
09/16/2002 |
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE |
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
| K023331 |
10/04/2002 |
BD VACUTAINER SST II PLUS TUBES |
BECTON DICKINSON & CO. |
| K003118 |
10/05/2000 |
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 |
ZCV ,INC. |
| K153033 |
10/19/2015 |
Digital Blood Pressure Monitor |
SUZHOU SUNSPIRI CO., LTD. |
| K974083 |
10/29/1997 |
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS |
OHMEDA MEDICAL |
| K974374 |
11/20/1997 |
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV |
OHMEDA MEDICAL |
| K965004 |
12/16/1996 |
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K024240 |
12/23/2002 |
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS |
BD |
| K222710 |
09/08/2022 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
| K232845 |
09/14/2023 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
| K210189 |
01/25/2021 |
Pac-Dent Denture Base Resin |
Pac-Dent, Inc. |
| K210412 |
02/11/2021 |
Pac-Dent Ceramic Nanohybrid Resin |
Pac-Dent, Inc. |
| K231060 |
04/13/2023 |
ProMin Dental Desensitizing Gel |
Belport Company, Inc., Gingi-Pak |
| K231793 |
06/20/2023 |
RODIN 3D Resin SPLINT, Hard/Flex |
Belport Company, Inc., Gingi-Pak |
| K223365 |
11/03/2022 |
RODIN Palette Naturalizing Kit |
Belport Company, Inc., Gingi-Pak |
| K210909 |
03/29/2021 |
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use |
Ezisurg Medical Co., Ltd. |
| K182217 |
08/15/2018 |
Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use |
Ezisurg (Suzhou) Medical Co., Ltd. |
| K241860 |
06/27/2024 |
Diode Laser Hair Removal System |
Beijing Winkonlaser Technology Limited. |
| K241073 |
04/19/2024 |
DZ-Tabone Intervertebral Body Fusion Device |
Shenzhen Dazhou Medical Technology Co., Ltd. |
| K241186 |
04/29/2024 |
Synthetic Bone Graft Particulate |
Shenzhen Dazhou Medical Technology Co., Ltd. |
| K182495 |
09/11/2018 |
Electronic Blood Pressure Monitor |
Shenzhen Jumper Medical Equipment Co., Ltd. |
| K180332 |
02/06/2018 |
17HK700G-W |
LG Electronics |
| K220559 |
02/28/2022 |
17HQ901G-B |
LG Electronics Inc. |
| K170899 |
03/27/2017 |
27HJ713S |
LG Electronics |
| K230845 |
03/28/2023 |
32HL512D, 31HN713D, 32HQ713D |
LG Electronics Inc. |
| K221061 |
04/11/2022 |
21HQ613D |
LG Electronics Inc. |
| K191188 |
05/03/2019 |
ASHK100G |
LG Electronics |
| K221394 |
05/13/2022 |
14HQ701G-B |
LG Electronics Inc. |
| K221434 |
05/17/2022 |
17HQ701G-B |
LG Electronics Inc. |
| K221461 |
05/19/2022 |
10HQ701G-B |
LG Electronics Inc. |
| K201777 |
06/29/2020 |
31HN713D |
LG Electronics Inc. |
| K191864 |
07/12/2019 |
21HK512D |
LG Electronics Inc. |
| K212295 |
07/22/2021 |
21HQ513D |
LG Electronics Inc. |
| K182348 |
08/29/2018 |
14HK701G-W |
LG Electronics Inc. |
| K232985 |
09/22/2023 |
24HR513C |
LG Electronics Inc. |
| K192925 |
10/16/2019 |
32HL512D |
LG Electronics Inc. |
| K223423 |
11/14/2022 |
32HQ713D |
LG Electronics Inc. |
| K223546 |
11/25/2022 |
14HQ721G-B |
LG Electronics Inc. |
| K183286 |
11/26/2018 |
17HK701G-W |
LG Electronics Inc. |
| K223789 |
12/19/2022 |
21HQ513D |
LG Electronics Inc. |
| K214044 |
12/27/2021 |
14HQ901G-B |
LG Electronics Inc. |
| K231753 |
06/15/2023 |
Oneday Implant Abutment |
Oneday Biotech Co., Ltd. |
| K160615 |
03/03/2016 |
ORTHODONTIC CERAMIC BRACKETS 1.1 |
TOMY, INC |
| K180718 |
03/19/2018 |
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES |
TOMY, Inc. |
| K250053 |
01/10/2025 |
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) |
Shenzhen Jiantuo Electronics Co., Ltd. |
| K211583 |
05/24/2021 |
Infrared Thermometer, Model: HW-1 |
Dongguan SIMZO Electronic Technology Co.Ltd. |
| K202670 |
09/14/2020 |
Nam illumination probe with chopper |
Oculight Ltd. |
| K063295 |
11/01/2006 |
ACON UTI URINARY TRACT INFECTION TEST STRIPS |
ACON LABORATORIES, INC. |
| K063418 |
11/13/2006 |
ACON DIGITAL THERMOMETER PROBE COVERS |
ACON LABORATORIES, INC. |
| K233140 |
09/27/2023 |
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) |
Hygea Medical Technology Co., Ltd. |
| K233806 |
11/29/2023 |
T2 Plus |
Osstem Implant Co., Ltd. |
| K242714 |
09/10/2024 |
Mobility Scooter (S-01); Mobility Scooter (S-02) |
Zhejiang Seedream Medical Equipment Co., Ltd. |
| K231554 |
05/30/2023 |
UniPearls« Embolic Microspheres |
Suzhou Haowei Medical Technology Co., Ltd. |