Search FDA 510(k) Database

6,431 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
7993–8016 of 174,061
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
Cleared Sep 20, 2023
Socrates Aspiration System
K223913 · NRY
Scientia Vascular, Inc.
Neurology · 265d
Cleared Sep 20, 2023
MedCAD AccuPlan Orthopedics System
K223421 · PBF
Medcad
Orthopedic · 314d
Cleared Sep 20, 2023
Cholestech LDX ™ System
K223179 · CGA
Alere San Diego, Inc.
Chemistry · 344d
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG...
K213987 · MXJ
Biokit, S.A.
Microbiology · 639d
Cleared Sep 19, 2023
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K232178 · KPR
DRGEM Corporation
Radiology · 57d
Cleared Sep 19, 2023
Millipede 088 Access Catheter
K231802 · QJP
Perfuze, Ltd.
Neurology · 91d