FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
9145–9168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231384 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 133d
Cleared Sep 22, 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 147d
Cleared Sep 22, 2023
qXR-CTR
K231149 · QIH
Qure.Ai Technologies
Radiology · 154d
Cleared Sep 22, 2023
T-SHAPE 2
K231092 · NUV
B&M S.R.L. Marketing Nel Benessere
General & Plastic Surgery · 157d
Cleared Sep 22, 2023
MicroMatrix® Flex
K230980 · KGN
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Sep 22, 2023
VISULAS yag
K230350 · HQF
Carl Zeiss Meditec, Inc.
Ophthalmic · 225d
Cleared Sep 22, 2023
Para-Fix External Fixation System
K230067 · LXT
New Paradigm Biomedical
Orthopedic · 256d
Cleared Sep 22, 2023
Access CEA
K223921 · DHX
Beckman Coulter, Inc.
Immunology · 267d
Cleared Sep 22, 2023
Jazz
K223659 · LLZ
Ai Medical AG
Radiology · 290d
Cleared Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · MRG
Immunostics Inc.,
Chemistry · 457d
Cleared Sep 22, 2023
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle...
K220179 · EFB
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 609d
Cleared Sep 21, 2023
CAREMIBRAIN
K232569 · KPS
General Equipment For Medical...
Radiology · 28d
Cleared Sep 21, 2023
QEVO System
K232159 · GWG
Carl Zeiss Meditec, AG
Neurology · 63d
Cleared Sep 21, 2023
Overjet Periapical Radiolucency Assist
K231678 · MYN
Overjet, Inc.
Radiology · 104d
Cleared Sep 21, 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
K231401 · FOZ
Poly Medicure Limited
General Hospital · 129d
Cleared Sep 21, 2023
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere...
K231248 · DYG
Edwards Lifesciencess, LLC
Cardiovascular · 143d
Cleared Sep 21, 2023
Pelvic Floor Muscle Stimulator
K230767 · KPI
Nanjing Vishee Medical Technology...
Gastroenterology & Urology · 185d
Cleared Sep 21, 2023
BTL-899F
K230467 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 212d
Cleared Sep 21, 2023
Integrity-SI® Fusion System
K230226 · OUR
OsteoCentric Technologies
Orthopedic · 237d
Cleared Sep 21, 2023
Servator P Plus SALF Solution
K230193 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 240d
Cleared Sep 21, 2023
Smart double sides wearable breast pump, Electric bilateral breast pump
K230102 · HGX
Huizhou Lvb Maternal and Infant...
Obstetrics & Gynecology · 251d
Cleared Sep 21, 2023
EGIS Biliary Single Bare Stent
K223354 · FGE
S&G Biotech, Inc.
Gastroenterology & Urology · 323d
Cleared Sep 21, 2023
Powder-Free Nitrile Examination Gloves
K223214 · LZA
Global Protection Corp.
General Hospital · 339d
Cleared Sep 20, 2023
CITRELOCK® DUO
K232592 · MBI
Acuitive Technologies, Inc.
Orthopedic · 26d