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
72625–72648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2003
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
K030930 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 59d
Cleared May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · FED
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 23, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K031076 · LYZ
Synmertex Co, Ltd.
General Hospital · 49d
Cleared May 23, 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 45d
Cleared May 23, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K031120 · LYZ
Synmertex Co, Ltd.
General Hospital · 45d
Cleared May 23, 2003
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
K031171 · LYZ
Synmertex Co, Ltd.
General Hospital · 39d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · MOS
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217 · LZO
Howmedica Osteonics
Orthopedic · 36d
Cleared May 23, 2003
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
K031262 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 32d
Cleared May 23, 2003
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
K031344 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 24d
Cleared May 23, 2003
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
K031361 · FPA
Deltec, Inc.
General Hospital · 23d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared May 23, 2003
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · BZH
Monaghan Medical Corp.
Anesthesiology · 9d
Cleared May 22, 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · MNW
Avita Corporation
Gastroenterology & Urology · 442d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 211d
Cleared May 22, 2003
EASYCUP
K023823 · JHI
Zer Hitech
Chemistry · 188d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · MRS
Microgenics Corp.
Toxicology · 83d
Cleared May 22, 2003
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · JXN
American Bio Medica Corp.
Toxicology · 66d
Cleared May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · GJS
Roche Diagnostics Corp.
Hematology · 66d
Cleared May 22, 2003
THERMACOOL TC SYSTEM
K031046 · GEI
Thermage, Inc.
General & Plastic Surgery · 50d
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110 · LPH
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · DTB
Medtronic Vascular
Cardiovascular · 30d