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
5209–5232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2024
Hudson RCI Comfort Flo® CubCannula™
K241778 · BTT
Medline Industries, LP
Anesthesiology · 182d
Cleared Dec 19, 2024
Broadway 8 Catheter
K241768 · QJP
Stryker Neurovascular
Neurology · 182d
Cleared Dec 19, 2024
Echo Intracranial Base Catheter
K241637 · QJP
Stryker Neurovascular
Neurology · 195d
Cleared Dec 19, 2024
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
K241322 · HGX
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 223d
Cleared Dec 19, 2024
System 83 Revolve Endoscope Washer/Disinfector
K241168 · FEB
Wassenburg Medical, Inc.
General Hospital · 237d
Cleared Dec 19, 2024
Shadow Catheter
K240885 · DQY
Simpson Interventions, Inc.
Cardiovascular · 262d
Cleared Dec 19, 2024
Quantum Mitohormesis (QMT) (M2101)
K240348 · IPF
Quantumtx Pte. , Ltd.
Physical Medicine · 318d
Cleared Dec 19, 2024
Therapy EC, Therapy XT
K232813 · NHN
Dmc Importacao E Exportacao DE...
Physical Medicine · 463d
Cleared Dec 18, 2024
3Delta UNlimited
K243720 · EBF
Deltamed GmbH
Dental · 15d
Cleared Dec 18, 2024
Xpert MRSA/SA SSTI
K243625 · NQX
Cepheid
Microbiology · 23d
Cleared Dec 18, 2024
Physica Porous Femoral Components
K243615 · MBH
Lima Corporate S.P.A.
Orthopedic · 26d
Cleared Dec 18, 2024
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
K243609 · MQV
Etex Corporation
Orthopedic · 26d
Cleared Dec 18, 2024
Klockner Kits
K243128 · KCT
SOADCO, S.L.
General Hospital · 79d
Cleared Dec 18, 2024
Tens & Ems Device (TU1080)
K242787 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 93d
Cleared Dec 18, 2024
Falcon/Xpress (Falcon/Xpress)
K242662 · JOP
Viasonix , Ltd.
Cardiovascular · 105d
Cleared Dec 18, 2024
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R,...
K242535 · FAJ
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 114d
Cleared Dec 18, 2024
Bluebird Single-Use Respiratory Effort Belt
K242424 · MNR
Cadwell Industries, Inc.
Anesthesiology · 125d
Cleared Dec 18, 2024
GENTAFIX® (1, 3, 3MV)
K242216 · MBB
Teknimed Sas
Orthopedic · 142d
Cleared Dec 18, 2024
Active System
K241395 · ILX
Caerus Corporation
Physical Medicine · 216d
Cleared Dec 18, 2024
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
K241132 · MQL
Artsmedia Denmark Aps
Obstetrics & Gynecology · 238d
Cleared Dec 18, 2024
ARTSMedia Semen Wash Medium
K241095 · MQL
Artsmedia Denmark Aps
Obstetrics & Gynecology · 240d
Cleared Dec 18, 2024
Lyka® PORT Needle Free Access Device (4170Y)
K241058 · FPA
Quest Medical, Inc.
General Hospital · 244d
Cleared Dec 18, 2024
Amethyst HP PTA OTW 0.035 Catheter
K241040 · LIT
Natec Medical , Ltd.
Cardiovascular · 246d
Cleared Dec 18, 2024
Respiratory Muscle Trainer
K240959 · BYI
Chongqing Moffy Innovation Technology...
Anesthesiology · 254d