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
21073–21096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2020
Livento Press, Soprano 10, Soprano
K192251 · EIH
Cendres & Metaux SA
Dental · 148d
Cleared CT Jan 15, 2020
Wattson Temporary Pacing Guidewire
K192454 · DQX
Vascular Solutions
Cardiovascular · 128d
Cleared Jan 15, 2020
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU...
K193225 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 54d
Cleared Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
K193493 · DGC
Siemens Healthcare Diagnostics, Inc.
Immunology · 29d
Cleared Jan 15, 2020
Arthrex SwiveLock Suture Anchor
K193503 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 14, 2020
Icare ic200
K190316 · HKY
Icare Finland OY
Ophthalmic · 335d
Cleared Jan 14, 2020
G210 InviCell Plus with SignipHy pH monitoring
K191020 · PUB
CooperSurgical, Inc.
Obstetrics & Gynecology · 272d
Cleared Jan 14, 2020
SABLE Expandable Spacer
K192115 · MAX
Globus Medical, Inc.
Orthopedic · 161d
Cleared Jan 14, 2020
Dental Pain Eraser
K192429 · LWM
Synapse Dental
Dental · 131d
Cleared Jan 14, 2020
Streamline TL Spinal Fixation System
K192800 · NKB
Pioneer Surgical Technology, Inc....
Orthopedic · 106d
Cleared Jan 14, 2020
Oragene®•Dx
K192920 · OYJ
DNA Genotek, Inc.
Chemistry · 90d
Cleared Jan 14, 2020
MiiS Horus Eye Anterior Camera
K193188 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 57d
Cleared Jan 14, 2020
XTRAC Momentum Excimer Laser System
K193478 · GEX
Strata Skin Sciences, Inc.
General & Plastic Surgery · 29d
Cleared Jan 13, 2020
Route 92 Medical Sheath System
K191717 · DQY
Route 92 Medical, Inc.
Neurology · 201d
Cleared Jan 13, 2020
Midwest Rhino XE and Air Motor M
K192409 · EFB
Dentsply Sirona
Dental · 131d
Cleared Jan 13, 2020
Erchonia Emerald
K192544 · OLI
Erchonia Corporation
General & Plastic Surgery · 119d
Cleared Jan 13, 2020
nva, nvp, and nvt
K193645 · MAX
Nvision Biomedical Technologies, Inc.
Orthopedic · 14d
Cleared Jan 11, 2020
TENS and EMS Stimulator, TENS Stimulator
K183074 · IPF
Astek Technology , Ltd.
Physical Medicine · 432d
Cleared Jan 10, 2020
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter...
K190878 · BTR
Salter Labs, Inc.
Anesthesiology · 281d
Cleared Jan 10, 2020
Cybird LED Curing Light
K191221 · EBZ
Dxm Co., Ltd.
Dental · 248d
Cleared Jan 10, 2020
IP Converter
K191678 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 200d
Cleared Jan 10, 2020
KardioScreen
K191692 · DPS
Imedrix Inc. (Formerly Piitech Inc.)
Cardiovascular · 199d
Cleared Jan 10, 2020
Nihon Kohden NKV-550 Series Ventilator System
K192307 · CBK
Nihon Kohden Orangemed, Inc.
Anesthesiology · 137d
Cleared Jan 10, 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with...
K192315 · LZA
Medline Industries, Inc.
General Hospital · 137d