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
15697–15720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2021
KARL STORZ ICG Imaging System
K212695 · OWN
Karl Storz Endoscopy America
General & Plastic Surgery · 82d
Cleared Nov 15, 2021
Circul8 Pro
K212731 · JOW
Ortho8, Inc.
Cardiovascular · 77d
Cleared Nov 15, 2021
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212765 · EIH
Bloomden Bioceramics (Hunan) Co., Ltd.
Dental · 76d
Cleared Nov 15, 2021
Air Compression Massager (Model LF-FT003)
K213000 · IRP
Wenzhou Lingfeng Electronic...
Physical Medicine · 56d
Cleared Nov 15, 2021
Axialis Ophthalmic Ultrasound System
K213254 · IYO
Quantel Medical
Radiology · 46d
Cleared Nov 15, 2021
Clarius Ultrasound Scanner
K213436 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Nov 15, 2021
DS Implants abutments provided with the EV connection
K213449 · NHA
Dentsply Sirona
Dental · 20d
Cleared Nov 15, 2021
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K213497 · MQB
H&abyz Co., Ltd.
Radiology · 14d
Cleared Nov 14, 2021
Spin Care Disposable Protective Mask Level 3
K212109 · FXX
Spintech, LLC
General Hospital · 131d
Cleared Nov 14, 2021
Surgical Face Mask
K212575 · FXX
Hubei Huanfu Plastic Products Co., Ltd.
General Hospital · 90d
Cleared Nov 13, 2021
Disposable Surgical Gowns
K210785 · FYC
Chongqing Litai Fashion Group Limited...
General Hospital · 242d
Cleared Nov 13, 2021
Surgical Face mask
K212264 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 116d
Cleared Nov 12, 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 452d
Cleared Nov 12, 2021
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
K202671 · NUH
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 424d
Cleared Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
K203184 · CFF
Sebia
Immunology · 381d
Cleared Nov 12, 2021
Wrap Accessory Electrodes
K210383 · GXY
Hi-Dow International, Inc.
Physical Medicine · 276d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · JWY
Biomerieux S.A.
Microbiology · 242d
Cleared Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
K210989 · HAW
Brainlab AG
Neurology · 224d
Cleared Nov 12, 2021
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™...
K211359 · PHX
Tornier, Inc.
Orthopedic · 193d
Cleared Nov 12, 2021
Intellijoint VIEW
K211876 · LLZ
Intellijoint Surgical, Inc.
Radiology · 148d
Cleared Nov 12, 2021
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212259 · EIH
Zirdent New Material Co., Ltd.
Dental · 115d
Cleared Nov 12, 2021
NightGuard Flex
K212448 · MQC
Sprintray, Inc.
Dental · 99d
Cleared Nov 12, 2021
Erchonia FX-405
K212595 · NHN
Erchonia Corporation
Physical Medicine · 88d
Cleared Nov 12, 2021
MAMMOVISTA B.smart
K212621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 86d