FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23137–23160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 85d
Cleared May 02, 2019
PASS LP Spinal System
K190376 · NKB
Medicrea International SA
Orthopedic · 72d
Cleared May 02, 2019
Ponto 4
K190540 · LXB
Oticon Medical AB
Ear, Nose, Throat · 59d
Cleared May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model...
K190560 · MUD
Nonin Medical, Inc.
General & Plastic Surgery · 58d
Cleared May 02, 2019
HYDRASHIFT 2/4 daratumumab
K190851 · CFF
Sebia
Immunology · 30d
Cleared May 01, 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · CAP
Instrumentation Industries, Inc.
Anesthesiology · 428d
Cleared May 01, 2019
Brush Biopsy Set
K182231 · FDX
Cook Incorporated
Gastroenterology & Urology · 257d
Cleared May 01, 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · HQB
Vitreq BV
Ophthalmic · 219d
Cleared May 01, 2019
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
K183394 · CCK
GE Healthcare Finland Oy
Anesthesiology · 145d
Cleared May 01, 2019
TruWave Disposable Pressure Transducer
K183413 · DXO
Edwards Lifeciences, LLC
Cardiovascular · 142d
Cleared May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · JWY
Biomerieux S.A.
Microbiology · 91d
Cleared May 01, 2019
Boomerang™ Anterior Cervical Plate System
K190227 · KWQ
Choicespine, LP
Orthopedic · 85d
Cleared May 01, 2019
VASERlipo System
K190551 · QPB
Solta Medical
General & Plastic Surgery · 57d
Cleared May 01, 2019
PowerX Lipo System
K190555 · QPB
Solta Medical
General & Plastic Surgery · 57d
Cleared May 01, 2019
HS Fiber
K190817 · GAT
Riverpoint Medical
General & Plastic Surgery · 30d
Cleared May 01, 2019
Synchro2 Support Guidewire
K190843 · MOF
Stryker
Neurology · 30d
Cleared Apr 30, 2019
BD Intelliport System
K182092 · PHC
Becton, Dickinson and Company
General Hospital · 270d
Cleared Apr 30, 2019
MRCAT Pelvis
K182888 · MUJ
Philips Medical Systems MR Finland
Radiology · 197d
Cleared Apr 30, 2019
Eclipse 2L
K183045 · MJN
Balt USA, LLC
Neurology · 179d
Cleared Apr 30, 2019
SambaScrew 3D SI Fusion System
K183342 · OUR
Orthofix, Inc.
Orthopedic · 148d
Cleared Apr 30, 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip...
K183540 · PNR
Neomed, Inc.
Gastroenterology & Urology · 131d
Cleared Apr 30, 2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
K190114 · KNT
Convatec Limited
Gastroenterology & Urology · 96d
Cleared Apr 30, 2019
Additive Cap
K190305 · KPE
International Medical Industries, Inc.
General Hospital · 77d
Cleared Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · DTE
Medtronic, Inc.
Cardiovascular · 29d