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
6745–6768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2024
Sample Preservative Fluid
K222771 · QBD
Hangzhou Bioer Technology Co., Ltd.
Microbiology · 651d
Cleared Jun 25, 2024
ASAHI Veloute
K241158 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 25, 2024
PMT Posterior Cervical Stabilization System (PCSS)
K241035 · MRW
Providence Medical Technology, Inc.
Orthopedic · 70d
Cleared Jun 25, 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001,...
K240824 · LZA
Ningxia Qiaoen Medical Technology...
General Hospital · 91d
Cleared Jun 25, 2024
VEA Align
K240582 · QIH
Eos Imaging
Radiology · 116d
Cleared Jun 25, 2024
Allograft Delivery Device (OFAC-C)
K233368 · FMF
Bioventus, LLC
General & Plastic Surgery · 267d
Cleared Jun 25, 2024
MyndMove, MyndMove 2.0
K233006 · GZI
Myndtec, Inc.
Physical Medicine · 277d
Cleared Jun 25, 2024
Venowave VW5
K232640 · JOW
Thermabright
Cardiovascular · 305d
Cleared Jun 25, 2024
NeoBeat, NeoBeat Mini
K232111 · MWI
Laerdal Medical AS
Cardiovascular · 347d
Cleared Jun 24, 2024
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
K241144 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jun 24, 2024
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S,...
K241120 · OHT
Qiaocheng LI (Dongguan) Medical...
General & Plastic Surgery · 62d
Cleared Jun 24, 2024
APEX 3D Total Ankle Replacement System
K240259 · HSN
Paragon 28, Inc.
Orthopedic · 145d
Cleared Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K233630 · FGB
Ambu A/S
Gastroenterology & Urology · 224d
Cleared Jun 24, 2024
NLZ Built-In Motor System
K233288 · EBW
Nakanishi, Inc.
Dental · 269d
Cleared Jun 24, 2024
Philips IntelliSite Pathology Solution 5.1
K233204 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 270d
Cleared Jun 24, 2024
SILKRO
K233123 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 271d
Cleared Jun 24, 2024
Copran Zri
K232952 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 277d
Cleared Jun 21, 2024
Invictus® Small Stature Spinal Fixation System
K241519 · NKB
Alphatec Spine, Inc.
Orthopedic · 23d
Cleared Jun 21, 2024
ToxiSeal™ Vial Adaptor with External Flip Balloon
K241476 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 28d
Cleared Jun 21, 2024
MOTUS PRO Family
K241459 · GEX
El.En S.P.A.
General & Plastic Surgery · 29d
Cleared Jun 21, 2024
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jun 21, 2024
M6-C™ Single Use, Disposable Instrumentation
K241117 · QLQ
Spinal Kinetics / Orthofix / Seaspine
Orthopedic · 59d
Cleared Jun 21, 2024
Medicom Sterilization Wrap
K240862 · FRG
Medicom Group, Inc.
General Hospital · 85d
Cleared Jun 21, 2024
CorDx Tyfast COVID-19 Ag Rapid Test
K240728 · QYT
CorDx, Inc.
Microbiology · 95d