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

Filters: Cleared only ×
176,076 results
71929–71952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2003
HEATER COOLER UNIT, MODEL HCU 30
K031544 · DWC
Jostra AB
Cardiovascular · 83d
Cleared Aug 07, 2003
CORRESTORE PATCH SYSTEM
K031586 · DXZ
Somanetics Corp.
Cardiovascular · 78d
Cleared Aug 07, 2003
BIFURCATED ALLERGY SKIN TESTING NEEDLE
K031630 · SCL
Precision Medical Products, Inc.
General Hospital · 72d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Aug 07, 2003
PRACTICEBUILDER 1-2-3
K031778 · LLZ
Erad Imagemedical Corp.
Radiology · 58d
Cleared Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...
K031924 · JIT
Ortho-Clinical Diagnostics
Chemistry · 45d
Cleared Aug 07, 2003
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 41d
Cleared Aug 07, 2003
N LATEX IGM
K032014 · CFN
Dade Behring, Inc.
Immunology · 38d
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