FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14305–14328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology
K221005 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 29, 2022
GIA Stapler with Tri-Staple Technology
K221006 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 28, 2022
Ortholock Anchorage Devices
K202691 · OAT
Craniofacial Technologies, Inc.
Dental · 590d
Cleared Apr 28, 2022
AngioCloud Service
K211713 · LLZ
Angiocloud, LLC
Radiology · 329d
Cleared Apr 28, 2022
RetinAI Discovery
K211715 · NFJ
Retinai Medical AG
Ophthalmic · 329d
Cleared Apr 28, 2022
EARP Interbody System
K212477 · MAX
Nvision Biomedical Technologies, Inc.
Orthopedic · 262d
Cleared Apr 28, 2022
G7® Vivacit-E® Freedom® Constrained Liner
K212512 · PBI
Zimmer, Inc.
Orthopedic · 261d
Cleared Apr 28, 2022
Planmed Verity
K213278 · OAS
Planmed OY
Radiology · 209d
Cleared Apr 28, 2022
Geistlich Wound Matrix PLUS
K213607 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 164d
Cleared Apr 28, 2022
Microthin Natural Rubber Latex Condom
K213921 · HIS
Suretex Limited
Obstetrics & Gynecology · 134d
Cleared Apr 28, 2022
DVR® Crosslock Wrist Spanning Plate (131849181)
K220244 · HRS
Pioneer Surgical Technology, Inc...
Orthopedic · 90d
Cleared Apr 28, 2022
EFAI RTSuite CT HN-Segmentation System
K220264 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Apr 28, 2022
Digital flat panel detector
K220536 · MQB
Iray Technology Taicang , Ltd.
Radiology · 63d
Cleared Apr 27, 2022
Philips Incisive CT
K212441 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 266d
Cleared Apr 27, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K213040 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 217d
Cleared Apr 27, 2022
Automatically Retractable Safety Syringe
K213077 · MEG
Zhejiang Lingyang Medical Apparatus...
General Hospital · 216d
Cleared Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 209d
Cleared CT Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
K213265 · OBO
Tomey Corporation
Ophthalmic · 209d
Cleared Apr 27, 2022
GyroStim
K220231 · LXV
Ultrathera Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 27, 2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
K220568 · MCW
Cardiovascualr Systems, Inc.
Cardiovascular · 58d
Cleared Apr 27, 2022
Venus BlissMAX
K220592 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 57d
Cleared Apr 27, 2022
EXTesia Introducer Sheath Set
K220604 · DYB
Curatia Medical Co.
Cardiovascular · 56d
Cleared Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
K220645 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 54d