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.

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

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175,820 results
150025–150048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
K850542 · JCA
International Technidyne Corp.
Hematology · 18d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
K850582 · CZP
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
K850583 · DEW
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C4
K850585 · DBI
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K850590 · DCK
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Mar 01, 1985
SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
K850660 · FTC
Suntech USA, Inc.
General & Plastic Surgery · 9d
Cleared Feb 28, 1985
NETHERY EXTREMITY FREEZING UNIT
K844246 · GEH
Howard J. Nethery & Assoc.
General & Plastic Surgery · 119d
Cleared Feb 28, 1985
HEARING AIDS MODELS IMS, ISD, ICL & IHX
K844478
The Ite Co.
Gastroenterology & Urology · 101d
Cleared Feb 28, 1985
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720
K844993 · FCG
Omnis Surgical, Inc.
Gastroenterology & Urology · 64d
Cleared Feb 28, 1985
MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN
K850129 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 45d
Cleared Feb 28, 1985
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K850133 · KGX
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 45d
Cleared Feb 28, 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · FAD
Mentor Corp.
Gastroenterology & Urology · 42d
Cleared Feb 28, 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 42d
Cleared Feb 28, 1985
ROTALOK SURGICAL HAND TABLE
K850251
Fairleigh Dickinson Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Feb 28, 1985
GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
K850285 · KOD
Premium Plastics, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 28, 1985
MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET
K850286 · LJE
Mentor Corp.
Gastroenterology & Urology · 35d
Cleared Feb 28, 1985
ELECTROSURGICAL PENCIL HOLDER 720
K850297 · GEI
Birtcher Corp.
General & Plastic Surgery · 35d
Cleared Feb 28, 1985
GYNASPYR VACUUM CURETTAGE UNIT
K850312 · HHI
Roseburg SA
Obstetrics & Gynecology · 34d
Cleared Feb 28, 1985
SUNSHOWER MODEL HU-01-12L
K850493 · FTC
Sunthetic Engineering, Inc.
General & Plastic Surgery · 20d
Cleared Feb 27, 1985
LASER PROTECTIVE EYESHIELD
K833679
Stefanovsky & Assoc.
General & Plastic Surgery · 540d
Cleared Feb 27, 1985
XANAR MODEL XSE-300 SMOKE EVACULATER
K844087 · FYD
Xanar, Inc.
General Hospital · 128d
Cleared Feb 27, 1985
ULTROSER G
K844413 · JJY
Lkb Instruments, Inc.
Chemistry · 105d
Cleared Feb 27, 1985
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423 · CDZ
Diagnostic Products Corp.
Chemistry · 104d