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
71329–71352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...
K032035 · CZW
Beckman Coulter, Inc.
Immunology · 37d
Cleared Aug 06, 2003
NANMA ADJUSTABLE CONSTRICTION RING
K030119 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 205d
Cleared Aug 06, 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 191d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · MNI
Ebi, L.P.
Orthopedic · 99d
Cleared Aug 06, 2003
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
K031401 · KTT
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 93d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · MBH
Implex Corp.
Orthopedic · 90d
Cleared Aug 06, 2003
HEMOGLOBIN A1C REAGENT SET
K031539 · LCP
Pointe Scientific, Inc.,
Chemistry · 82d
Cleared Aug 06, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K031577 · JJY
Cliniqa Corporation
Chemistry · 78d
Cleared Aug 06, 2003
TOX AMMONIA CALIBRATOR
K031683 · JIX
Bayer Healthcare, LLC
Chemistry · 68d
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 06, 2003
CARDIOQ, MODEL 9051-7005
K031706 · DPW
Deltex Medical
Cardiovascular · 65d
Cleared Aug 06, 2003
CADSTREAM
K031779 · LLZ
Confirma, Inc.
Radiology · 57d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · DKB
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
K031943 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Aug 06, 2003
TRI-LOOP MICROWAVE ABLATION PROBE
K032047 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 35d
Cleared Aug 06, 2003
BENCO ADMIX
K032152 · EJJ
Southern Dental Industries, Inc.
Dental · 70d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Medison America, Inc.
Radiology · 8d
Cleared Aug 05, 2003
DIGITAL TEMPERATURE MONITOR
K030219 · FLL
Kang Ying Medical Appliances, Inc.
General Hospital · 195d
Cleared Aug 05, 2003
LIFESYNE SYSTEMS
K030795 · DRG
Gmp/Companies, Inc.
Cardiovascular · 146d
Cleared Aug 05, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282 · LJT
LeMaitre Vascular, Inc.
General Hospital · 105d
Cleared Aug 05, 2003
CARRIER TIPS
K031461 · ELC
Dentsply Intl.
Dental · 89d
Cleared Aug 05, 2003
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
K031717 · CDZ
Roche Diagnostics Corp.
Chemistry · 63d