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
11113–11136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2023
SafeAir combi (SFR-combi-US)
K223932 · GEI
Lina Medical Aps
General Hospital · 117d
Cleared Apr 26, 2023
PYXIS 3D Titanium Cage System
K223868 · MAX
GS Medical Co., Ltd.
Orthopedic · 124d
Cleared Apr 26, 2023
Access PCT
K222996 · PTF
Beckman Coulter, Inc.
Microbiology · 210d
Cleared Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS...
K222584 · FET
Olympus Medical Systems Corporation
Gastroenterology & Urology · 243d
Cleared Apr 26, 2023
Endo Motor
K222548 · EKX
Shenzhen Perfect Medical Instruments...
Dental · 246d
Cleared Apr 25, 2023
Konicaminolta DI-X1
K230906 · LLZ
Konica Minolta, Inc.
Radiology · 25d
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594 · PDU
Avinger, Inc.
Cardiovascular · 53d
Cleared Apr 25, 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL,...
K230549 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 56d
Cleared Apr 25, 2023
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
K230503 · DRF
Boston Scientific
Cardiovascular · 60d
Cleared Apr 25, 2023
iCAC Device
K230223 · JAK
Bunkerhill, Inc.
Radiology · 89d
Cleared Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218 · NHA
Dental Direkt GmbH
Dental · 89d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204 · HRS
Vilex, LLC
Orthopedic · 90d
Cleared Apr 25, 2023
TMINI™ Miniature Robotic System
K230202 · OLO
THINK Surgical, Inc.
Orthopedic · 90d
Cleared Apr 25, 2023
MiVu™ Esophageal Endo Cap
K230056 · QIS
Diversatek Healthcare
Gastroenterology & Urology · 106d
Cleared Apr 25, 2023
Wallaby 017 Micro Catheter
K223139 · KRA
Wallaby Medical
Neurology · 203d
Cleared Apr 25, 2023
Ceevra Reveal 3
K222676 · QIH
Ceevra, Inc.
Radiology · 231d
Cleared Apr 25, 2023
NITRO Interbody Fusion Cage System Family
K220513 · ODP
Ctl Medical Corporation
Orthopedic · 427d
Cleared Apr 24, 2023
RAIN Sheath™ Tibial Pedal Introducer
K230704 · DYB
Cordis US Corp
Cardiovascular · 41d
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core...
K230140 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
Klockner Abutments
K230103 · NHA
SOADCO, S.L.
Dental · 101d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372 · LZG
Insulet Corporation
Chemistry · 171d
Cleared Apr 24, 2023
STR8 Clear Aligner
K223141 · NXC
Str8 Oral Care
Dental · 202d
Cleared Apr 24, 2023
SmartGUIDE deflectable hydrophilic guidewire
K222690 · MOF
Artiria Medical SA
Neurology · 230d