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
17449–17472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2021
Metapex Plus
K202617 · KIF
Meta Biomed Co., Ltd.
Dental · 217d
Cleared Apr 14, 2021
BriefCase, RIB Fractures Triage (RibFx)
K202992 · QFM
Aidoc Medical , Ltd.
Radiology · 196d
Cleared CT Apr 14, 2021
Artimes pro Balloon Dilatation Catheter
K203390 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 147d
Cleared Apr 14, 2021
F&P Visairo NIV Mask Range
K203449 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 142d
Cleared Apr 14, 2021
CX30N (CX30PQX)
K210493 · PGY
Wide Corporation
Radiology · 54d
Cleared Apr 14, 2021
HydroMARK Breast Biopsy Site Marker
K210752 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared Apr 14, 2021
Cannulated Fasteners and Nuts
K210754 · HWC
OsteoCentric Technologies
Orthopedic · 30d
Cleared Apr 13, 2021
IDS Cortisol
K202136 · CGR
Immunodiagnostic Systems , Ltd.
Chemistry · 256d
Cleared Apr 13, 2021
SR-1 Skin Treatment System
K202884 · ONG
Avava, Inc.
General & Plastic Surgery · 197d
Cleared Apr 13, 2021
EndoPilot2
K202906 · ELC
Schlumbohm GmbH & Co. KG
Dental · 196d
Cleared Apr 13, 2021
RetCam Envision
K203500 · HKI
Natus Medical Incorporated Dba...
Ophthalmic · 134d
Cleared Apr 13, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable,...
K210088 · GCJ
Stryker
General & Plastic Surgery · 90d
Cleared Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
K210197 · HKI
Crystalvue Medical Corporation
Ophthalmic · 78d
Cleared Apr 13, 2021
Volition Plating System
K210658 · HRS
Ortho Solutions UK , Ltd.
Orthopedic · 40d
Cleared Apr 13, 2021
Flyte
K210764 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 12, 2021
Idys ALIF 3DTi
K200919 · MAX
Clariance
Orthopedic · 371d
Cleared Apr 12, 2021
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -...
K202679 · KPS
Mcgovern Medical School
Radiology · 209d
Cleared Apr 12, 2021
Invacare Platinum 5NXG Oxygen Concentrator
K203210 · CAW
Invacare Corporation
Anesthesiology · 164d
Cleared Apr 12, 2021
OMNIVision system
K203751 · OLO
Corin USA
Orthopedic · 110d
Cleared Apr 12, 2021
Athena Surgical RMUS System
K210087 · OTN
Athena Surgical, LLC
Gastroenterology & Urology · 89d
Cleared Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal...
K210436 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 59d
Cleared Apr 12, 2021
Ligament Staple
K210456 · JDR
Medacta International S.A.
Orthopedic · 55d
Cleared Apr 12, 2021
SecurAcath
K210629 · OKC
Interrad Medical, Inc.
General Hospital · 41d
Cleared Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K210900 · OWB
Canon Medical Systems Corporation
Radiology · 17d