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
14401–14424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 15, 2022
RayStation 11B
K220141 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 87d
Cleared Apr 15, 2022
Mako Total Knee Application
K220459 · OLO
Mako Surgical Corp.
Orthopedic · 57d
Cleared Apr 15, 2022
XD
K220779 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Apr 15, 2022
FootHold System
K220797 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Apr 15, 2022
SURGIVISIO Device
K220946 · OWB
Ecential Robotics
Radiology · 14d
Cleared Apr 14, 2022
Coala Heart Monitor
K212163 · DPS
Coala Life AB
Cardiovascular · 276d
Cleared Apr 14, 2022
MagnetOs Flex Matrix
K213959 · MQV
Kuros Biosciences B.V
Orthopedic · 118d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · LON
bioMerieux, Inc.
Microbiology · 113d
Cleared Apr 14, 2022
Amputee Garment for use with Lympha Press Optimal Plus
K214053 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 108d
Cleared Apr 14, 2022
High Retention Attachment System
K220252 · NHA
Zest Anchors, LLC
Dental · 73d
Cleared Apr 14, 2022
Yushan X-Ray Flat Panel Detector with DROC
K220510 · MQB
Innocare Optoelectronics Corp.
Radiology · 51d
Cleared Apr 14, 2022
Disposable Medical Nitrile Examination Gloves
K220561 · LZA
Nanjing Universal Medical Equipment...
General Hospital · 45d
Cleared Apr 14, 2022
TeleScan
K220767 · LLZ
Bb Imaging
Radiology · 29d
Cleared Apr 13, 2022
Bendit21 Microcatheter
K203842 · QJP
Bend IT Technologies, Ltd.
Neurology · 468d
Cleared Apr 13, 2022
Cannulated Compression Device System
K210146 · HWC
Orthopedic Designs North America, Inc.
Orthopedic · 447d
Cleared Apr 13, 2022
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number...
K210148 · FYC
Flomak Tekstil Makine Muh. Mum. Taah....
General Hospital · 447d
Cleared Apr 13, 2022
BIOTEQ Drainage Catheter BT-PDS-series
K210419 · FGE
Bioteque Corporation
Gastroenterology & Urology · 426d
Cleared Apr 13, 2022
MCL 31 Dermablate System
K210634 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 406d
Cleared Apr 13, 2022
ZENEX Implant System
K211090 · DZE
Izenimplant Co., Ltd.
Dental · 366d
Cleared Apr 13, 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible...
K212202 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 273d
Cleared Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
K212245 · OLO
Brainlab AG
Orthopedic · 268d
Cleared Apr 13, 2022
Sensuva Premium Silicone Personal Lubricant
K212260 · NUC
Valencia Naturals, Inc.
Obstetrics & Gynecology · 267d
Cleared Apr 13, 2022
Keffort (MC-100, MC-100A)
K213133 · KPI
Oriental Inspiration Limited
Gastroenterology & Urology · 198d