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"
553–576 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 04, 2022
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231,...
K212257 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 289d
Cleared May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
K220645 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Apr 26, 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K220222 · OHT
Shenzhen Yuwei Electronic Technology...
General & Plastic Surgery · 90d
Cleared Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K220152 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · NUH
Ningbo Medkinetic Medical Device Co.,...
Neurology · 256d
Cleared Apr 12, 2022
LED Therapy Device (Planar LED/Planar LED mini)
K220103 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 11, 2022
Intense Pulsed Light (IPL) System
K212881 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 213d
Cleared Apr 05, 2022
Digital thermometer, Model DT101, DT102
K213746 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Apr 01, 2022
TENS & PMS Unit
K220005 · NUH
Shenzhen Yuehua Xinsen Technology...
Neurology · 87d
Cleared Mar 31, 2022
Air Compression Therapy Device, model: ST-502
K213745 · IRP
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 122d
Cleared Mar 28, 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
K214113 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Mar 25, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10...
K220242 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared Mar 25, 2022
Nebulizer
K212395 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 235d
Cleared Mar 10, 2022
D-Laser Blue, D-Laser 16
K210367 · NVK
Guilin Woodpecker Medical Instrument...
Dental · 395d
Cleared Mar 08, 2022
TENS & EMS DEVICE (Model: FM-B2403A)
K213741 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 99d
Cleared Mar 04, 2022
TE Air Diagnostic Ultrasound System
K220051 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 57d
Cleared Mar 04, 2022
Surgical Mask
K213358 · FXX
Shenzhen Safesecure Medical Infection...
General Hospital · 143d
Cleared Mar 03, 2022
TENS & EMS Device
K213835 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 84d
Cleared Mar 01, 2022
Sterile Disposable Temperature Probe
K212945 · FLL
Shenzhen Envisen Industry Co., Ltd.
General Hospital · 167d
Cleared Feb 25, 2022
Ear Thermometer, Model ET005, ET008, ET009
K213084 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 155d
Cleared Feb 25, 2022
Levator Elite (Model LE9011)
K213043 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 156d
Cleared Feb 25, 2022
Pulse Oximeter
K212300 · DQA
Shenzhen Mericonn Technology Co., Ltd.
Anesthesiology · 218d