FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8881–8904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 20, 2023
Catalyst R1 Reverse Shoulder System
K232583 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 26d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · EOQ
Ambu A/S
Ear, Nose, Throat · 26d
Cleared Sep 20, 2023
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular...
K232556 · LPH
Depuy Ireland UC
Orthopedic · 28d
Cleared Sep 20, 2023
LED Spectrum therapy instrument
K231894 · GEX
Shenzhenshi Sincoheren S&T...
General & Plastic Surgery · 84d
Cleared Sep 20, 2023
1788 4K Camera System with Advanced Imaging Modality
K231854 · OWN
Stryker
General & Plastic Surgery · 89d
Cleared Sep 20, 2023
Rology Teleradiology Platform (v.1.22.1103)
K231385 · LLZ
Rology, Inc.
Radiology · 131d
Cleared Sep 20, 2023
Insufflator (OPTO-IFL1000)
K231342 · HIF
Guangdong Optomedic Technologies, Inc.
Obstetrics & Gynecology · 134d
Cleared Sep 20, 2023
TULSA-PRO System
K230692 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Sep 20, 2023
AirSeal iFS System
K230239 · HIF
Conmed Corporation
Obstetrics & Gynecology · 233d
Cleared Sep 20, 2023
Insulin Pen Needle
K230043 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 257d
Cleared Sep 20, 2023
Mpact Extension
K230011 · LPH
Medacta International S.A.
Orthopedic · 260d