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"
169–192 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jul 10, 2025
Microcurrent Facial Device (CEC101, EE0101, EEI101)
K244004 · NFO
Shenzhen Dachi Communication Co., Ltd.
Neurology · 196d
Cleared Jul 08, 2025
Single-use Ureteral Access Sheath
K250695 · FED
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 123d
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · LJE
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 135d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204 · FET
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07,...
K251000 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 90d
Cleared Jun 26, 2025
Doppler FHR Detector (BF-500D+, BF-560)
K242846 · KNG
Shenzhen Bestman Instrument Co., Ltd.
Obstetrics & Gynecology · 279d
Cleared Jun 25, 2025
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
K250966 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 86d
Cleared Jun 23, 2025
Ear Thermometer (EAR-E101)
K250470 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 125d
Cleared Jun 20, 2025
LED Facial Mask
K243978 · OHS
Shenzhen Sunsred Technology Co.,Ltd
General & Plastic Surgery · 179d
Cleared Jun 20, 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · FLL
Shenzhen Medke Technology Co., Ltd.
General Hospital · 267d
Cleared Jun 18, 2025
Extracorporeal Shock Wave Lithotripter (U200)
K242922 · LNS
Shenzhen Wikkon Precision...
Gastroenterology & Urology · 267d
Cleared Jun 17, 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 76d
Cleared Jun 16, 2025
MAGNETOM Flow.Ace
K250436 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 122d
Cleared Jun 09, 2025
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO,...
K250830 · OHS
Shenzhen Sungrow Led Technology Co.,...
General & Plastic Surgery · 82d
Cleared Jun 06, 2025
Baby Nasal Aspirator (BN002)
K251450 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 28d
Cleared Jun 05, 2025
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
K250467 · OAP
Shenzhen Idea Light Limited
General & Plastic Surgery · 107d
Cleared May 30, 2025
KALA Red Light Face Mask (KALA-01)
K250581 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 92d
Cleared May 30, 2025
Wearable Breast Pump (Model S21)
K250368 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
Motif Aura Glow breast pump (Model Motif Aura Glow)
K250365 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
TE Air Diagnostic Ultrasound System
K250024 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 144d
Cleared May 29, 2025
TENS AND EMS (TENS and Muscle Stimulator) ( Model...
K243856 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 164d
Cleared May 28, 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793 · EOQ
Shenzhen Insighters Medical...
Ear, Nose, Throat · 254d
Cleared May 23, 2025
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01...
K250938 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 56d
Cleared May 22, 2025
Solawave 2-in-1 Skincare Mini (Model: 61043)
K250532 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 87d