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
18745–18768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2020
Z-Span Plate System
K202624 · KWQ
Zavation Medical Products, LLC
Orthopedic · 55d
Cleared Nov 03, 2020
Palm NRG cellulite and muscle toning body device
K191940 · PBX
Heat IN A Click
General & Plastic Surgery · 473d
Cleared Nov 03, 2020
Blue Beacon Submucosal Injectable Solution
K200071 · PLL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 295d
Cleared Nov 03, 2020
PMMA Block
K201683 · EBG
Huge Dental Material Co., Ltd.
Dental · 134d
Cleared Nov 03, 2020
FlareHawk Interbody Fusion System
K202198 · MAX
Integrity Implants, Inc.
Orthopedic · 90d
Cleared Nov 02, 2020
e-Motion M25
K192618 · ITI
Alber GmbH
Physical Medicine · 406d
Cleared Nov 02, 2020
SpeediCath Compact Set
K192904 · GBM
Coloplast
Gastroenterology & Urology · 384d
Cleared Nov 02, 2020
Midas Rex Attachments and Dissecting Tools
K202552 · OLO
Medtronic Powered Surgical Solutions...
Orthopedic · 60d
Cleared Nov 02, 2020
Ellusa Bipolar Wands
K202558 · GEI
Ellusa, LLC
General & Plastic Surgery · 59d
Cleared Nov 02, 2020
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and...
K202562 · GEI
Ellusa, LLC
General & Plastic Surgery · 59d
Cleared Nov 02, 2020
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX...
K203032 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 28d
Cleared Oct 30, 2020
eCordum Cardiac Monitor (eCordum CM)
K193296 · DXH
Ecordum, Inc.
Cardiovascular · 338d
Cleared Oct 30, 2020
Smart Alarm Interface
K193421 · MSX
Boxview, LLC
Cardiovascular · 326d
Cleared Oct 30, 2020
ScalpelCric
K200190 · BWC
VBM Medizintechnik GmbH
Anesthesiology · 277d
Cleared Oct 30, 2020
UNiD IB3D ALIF
K200316 · MAX
Medicrea International SA
Orthopedic · 266d
Cleared Oct 30, 2020
AutoContour
K200323 · QKB
Radformation, Inc.
Radiology · 263d
Cleared Oct 30, 2020
Patent Hemostasis Band (PH Band)
K201695 · DXC
Medical Ingenuities
Cardiovascular · 130d
Cleared Oct 30, 2020
T-Lite
K201988 · IYN
Sonoscanner
Radiology · 105d
Cleared Oct 30, 2020
WRDensity by Whiterabbit.ai
K202013 · QIH
Whiterabbit.Ai, Inc.
Radiology · 101d
Cleared Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use...
K202157 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 88d
Cleared Oct 30, 2020
Atlas Spine Rebar (Ti) Spacer System
K202302 · ODP
Atlas Spine, Inc.
Orthopedic · 77d
Cleared Oct 30, 2020
Aulisa Multiple Patient Digital Vital Sign Monitoring System
K202497 · MSX
Taiwan Aulisa Medical Devices...
Cardiovascular · 60d
Cleared Oct 30, 2020
HS30 Diagnostic Ultrasound System
K202556 · IYN
Samsung Medison Co., Ltd.
Radiology · 57d
Cleared Oct 30, 2020
Longeviti ClearFit Cranial Implant
K202901 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 31d