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
14281–14304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2022
Ultiri Measurement System
K220243 · DQK
Abbott Medical
Cardiovascular · 92d
Cleared Apr 29, 2022
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956 · DHN
Zeus Scientific, Inc.
Immunology · 654d
Cleared Apr 29, 2022
Alinity m STI Assay
K202977 · QEP
Abbott Molecular, Inc.
Microbiology · 576d
Cleared Apr 29, 2022
Bindex BI-2
K211350 · MUA
Bone Index Finland , Ltd.
Radiology · 361d
Cleared Apr 29, 2022
Disposable Surgical Isolation Gown
K212422 · FYC
Crown Name Disposable Hygiene...
General Hospital · 268d
Cleared Apr 29, 2022
BONREE Nelaton Catheter
K212430 · EZD
Bonree Medical Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Apr 29, 2022
Safety Pen Needle for Single Use, Insulin Pen Needles
K212514 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 262d
Cleared Apr 29, 2022
SteriTite Container System with MediTray Products
K212711 · KCT
Case Medical, Inc.
General Hospital · 246d
Cleared Apr 29, 2022
Monarch Platform, Urology
K213334 · FGB
Auris Health, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 29, 2022
TIA Tip, Cariosity, Transillumination Accessory Tip
K213482 · NTK
D4D Technologies, LLC
Dental · 182d
Cleared Apr 29, 2022
BodyTom 64
K213649 · JAK
Neurologica Corporation
Radiology · 161d
Cleared Apr 29, 2022
FreedomEdge Syringe Infusion System
K214045 · FRN
Repro-Medical System, Inc., Dba Koru...
General Hospital · 123d
Cleared Apr 29, 2022
Camber Spine Navigation System
K220038 · OLO
Camber Spine Technologies
Orthopedic · 114d
Cleared Apr 29, 2022
LISA Laser Surgical Fibers
K220189 · GEX
Omni-Guide Holdings, Inc.
General & Plastic Surgery · 95d
Cleared Apr 29, 2022
Hand Diagnostic Radiography Imaging System
K220271 · KPR
Nanoray Biotech Co., Ltd.
Radiology · 88d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d
Cleared Apr 29, 2022
ExacTrac Dynamic
K220338 · IYE
Brainlab AG
Radiology · 81d
Cleared Apr 29, 2022
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
K220383 · KRD
Okami Medical
Cardiovascular · 78d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 29, 2022
aPROMISE X
K220590 · LLZ
Exini Diagnostics AB
Radiology · 59d
Cleared Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
K220608 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 2022
Oryx Cloud Imaging
K220684 · LLZ
Oryx Dental Software, Inc.
Radiology · 52d
Cleared Apr 29, 2022
Elite Biomedical Solutions Dose Request Cord
K220695 · MRZ
Elite Biomedical Solutions
General Hospital · 51d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899 · QME
Oxehealth Limited
Cardiovascular · 32d