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"
313–336 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jul 02, 2024
Ultrasonic Scaler...
K240707 · ELC
Shenzhen Micro Electric Intelligence...
Dental · 109d
Cleared Jul 01, 2024
Wearable Breast Pump (Model S32)
K240536 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 126d
Cleared Jul 01, 2024
Pulse Oximeter (AOJ-70A)
K232989 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 283d
Cleared Jun 28, 2024
Ultrasonic Fetal Doppler
K233823 · KNG
Shenzhen Jamr Technology Co., Ltd.
Obstetrics & Gynecology · 210d
Cleared Jun 21, 2024
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07...
K240649 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 106d
Cleared Jun 18, 2024
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B,...
K240583 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 109d
Cleared Jun 17, 2024
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K240684 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 14, 2024
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39,...
K240729 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 88d
Cleared Jun 14, 2024
G-Vitri™ Vitrification Straw
K240002 · MQK
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 164d
Cleared Jun 13, 2024
Giftlife™ Fertilization Medium
K240149 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 146d
Cleared Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 57d
Cleared Jun 10, 2024
Wrap Accessory Electrodes (GMX-ABSBELT01
K240108 · GXY
Gymmax Technology Shenzhen Co., Ltd.
Physical Medicine · 146d
Cleared Jun 07, 2024
Electrocardiograph, model: ECG301
K232816 · DPS
Shenzhen LE Medical Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 05, 2024
ShockPhysio Mobile (model SW3200 Basic)
K240358 · ISA
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 120d
Cleared May 31, 2024
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
K240969 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 52d
Cleared May 22, 2024
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A,...
K241106 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 30d
Cleared May 22, 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · QSY
Ushare Medical, Inc.
General & Plastic Surgery · 131d
Cleared May 14, 2024
Electric Breast Pump (BRP-301)
K233913 · HGX
Aoj Health Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 266d
Cleared May 10, 2024
Organic Cotton Tampon
K240708 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 56d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 93d
Cleared May 10, 2024
Oocyte Flushing & Retrieval Medium
K234023 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 142d
Cleared Apr 26, 2024
Rhinolaryngoscope system
K232435 · EOB
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 256d
Cleared Apr 24, 2024
IPL Home Use Hair Removal Device (SJ15)
K240093 · OHT
Shenzhen Shuge Medical Beauty Devices...
General & Plastic Surgery · 103d