FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,163 results for "shenzhen"
985–1008 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jun 30, 2015
V60 Anesthetic Vaporizer
K150167 · CAD
Shenzhen Mindray Bio-Medical...
Anesthesiology · 155d
Cleared Jun 12, 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 148d
Cleared Jun 11, 2015
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.:...
K150373 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 118d
Cleared Jun 03, 2015
Pulse Oximeter, Models PC-66A
K150093 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 138d
Cleared May 02, 2015
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
K143734 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 123d
Cleared Apr 17, 2015
DIODE LASER HAIR REMOVAL SYSTEM
K142186 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 252d
Cleared Apr 13, 2015
Monopolar Laparascopic Accessories
K142208 · GEI
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 245d
Cleared Apr 10, 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 71d
Cleared Apr 03, 2015
Digital Automatic Wrist Blood Pressure Monitor MD2400
K143733 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 94d
Cleared Apr 03, 2015
ELECTRONIC BLOOD PRESSURE MONITOR
K141683 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 284d
Cleared Mar 20, 2015
SUMMED HIGH PRESSURE LINE
K140356 · DQO
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 401d
Cleared Feb 13, 2015
DIGITAL ELECTROCARDIOGRAPH
K141946 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 211d
Cleared Jan 23, 2015
A7 Anesthesia System
K142552 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 135d
Cleared Jan 22, 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 392d
Cleared Jan 02, 2015
TE7 Diagnostic Ultrasound System
K143472 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Dec 22, 2014
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
K143195 · MHX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 46d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795 · MAV
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 364d
Cleared Nov 14, 2014
Panorama Patient Monitoring Network
K142601 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 64d
Cleared Nov 14, 2014
GARMENT ELECTRODES
K141076 · GXY
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 203d
Cleared Nov 13, 2014
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
K141593 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 153d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Oct 31, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
K142088 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 91d
Cleared Oct 09, 2014
BLOOD PRESSURE MONITOR
K141416 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 133d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 125d