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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90961–90984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1998
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
K972119 · FAT
Medovations, Inc.
Gastroenterology & Urology · 242d
Cleared Feb 02, 1998
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · HEX
CooperSurgical, Inc.
Obstetrics & Gynecology · 203d
Cleared Feb 02, 1998
ULTRAMIST 2000
K972657 · CAF
Texas Medical Industries, Inc.
Anesthesiology · 202d
Cleared Feb 02, 1998
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
K974027 · CDP
Alfa Biotech (Uk) , Ltd.
Chemistry · 102d
Cleared Feb 02, 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · FPA
Medtronic Minimed
General Hospital · 89d
Cleared Feb 02, 1998
UTERINE MANIPULATOR/INJECTOR
K974357 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 75d
Cleared Feb 02, 1998
PERMAFLO
K974413 · EBF
Ultradent Products, Inc.
Dental · 70d
Cleared Feb 02, 1998
COMPOLUTE APLICAP
K974458 · EMA
Espe Dental-Medizin GmbH & Co.Kg.
Dental · 69d
Cleared Feb 02, 1998
DBEST ONE-STEP OVULATION TEST
K974508 · CEP
Ameritek, Inc.
Chemistry · 63d
Cleared Feb 02, 1998
RANDOX CALCIUM
K974607 · CJY
Randox Laboratories, Ltd.
Chemistry · 54d
Cleared Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
K980028 · CKA
Trace America, Inc.
Chemistry · 28d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · MBI
Mitek Products
Orthopedic · 381d
Cleared Jan 30, 1998
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK...
K970445 · MHX
Pace Tech Medical Monitors, Inc.
Cardiovascular · 359d
Cleared Jan 30, 1998
PHILIPS EASYVISION
K971965 · LLZ
Philips Medical Systems, Inc.
Radiology · 247d
Cleared Jan 30, 1998
EXCEL AV STIM 1000
K972157 · GWJ
Excel Tech. , Ltd.
Neurology · 235d
Cleared Jan 30, 1998
ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
K972298 · GCJ
The Altomec Corp.
General & Plastic Surgery · 225d
Cleared Jan 30, 1998
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
K973499 · HRX
Xomed, Inc.
Orthopedic · 136d
Cleared Jan 30, 1998
UROSURGE UROSTENT
K973504 · FAD
Princeton Regulatory Assoc.
Gastroenterology & Urology · 136d
Cleared Jan 30, 1998
CAPIOX HEMOCONCENTRATOR
K973516 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 135d
Cleared Jan 30, 1998
SOMNUS TISSUE COAGULATING ELECTRODE
K973701 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 123d
Cleared Jan 30, 1998
TRUMP-IT II AND MAGNUM 250
K973814 · GCJ
Valley West, Inc.
General & Plastic Surgery · 115d
Cleared Jan 30, 1998
IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS...
K974126 · DZE
Imcor
Dental · 88d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136 · MBI
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 30, 1998
UROMED NEEDLE GRASPER
K974137 · OCW
Uromed Corp.
Gastroenterology & Urology · 88d