Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80569–80592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE...
K010426 · LJT
Sims Deltec, Inc.
General Hospital · 23d
Cleared Mar 08, 2001
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602,...
K010442 · ETB
Heinz Kurz
Ear, Nose, Throat · 22d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856 · DQY
Abbott Vascular, Inc.
Cardiovascular · 261d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Mar 07, 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · BTT
Vital Signs, Inc.
Anesthesiology · 209d
Cleared Mar 07, 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · DQY
Concentric Medical, Inc.
Cardiovascular · 155d
Cleared Mar 07, 2001
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
K003550 · CCK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 110d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 91d
Cleared Mar 07, 2001
GENERAL SURGICAL LAPAROSCOPES
K003803 · GCJ
Global Endoscopy, Inc.
General & Plastic Surgery · 89d
Cleared Mar 07, 2001
FLEXVIEW CLINICAL MONITORING SYSTEM
K003998 · MSX
Data Critical Corp.
Cardiovascular · 71d
Cleared Mar 07, 2001
SLT DIFFUSER FIBER
K010041 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 61d
Cleared Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289 · MOB
Scimedx Corp.
Immunology · 35d
Cleared Mar 07, 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · DWJ
Medivance, Inc.
Cardiovascular · 30d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · KOD
Endocare, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · LFR
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · HRX
Linvatec Corp.
Orthopedic · 238d
Cleared Mar 06, 2001
FETAL ASSIST
K002548 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 201d
Cleared Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · FPA
Quest Medical, Inc.
General Hospital · 189d
Cleared Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K003765 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 06, 2001
CARIS SITE MARKER
K003777 · FZP
Artemis Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 06, 2001
INJEX 50 SYSTEM
K003864 · KZE
Equidyne Systems, Inc.
General Hospital · 83d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Mar 06, 2001
D.SIGN 30
K010381 · EJH
Ivoclar North America, Inc.
Dental · 26d
Cleared Mar 06, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K010419 · DQA
Masimo Corp.
Anesthesiology · 22d