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
76345–76368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2002
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K020535 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE OMNIBED
K020543 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
K020547 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
K020561 · IYO
Tomtec Imaging Systems GmbH
Radiology · 78d
Cleared May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
K020566 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 78d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · MRR
Dade Behring, Inc.
Chemistry · 64d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
VORTEX VALVED HOLDING CHAMBER
K020944 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 45d
Cleared May 09, 2002
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER
K021054 · LMC
Codonics, Inc.
Radiology · 38d
Cleared May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K021166 · FDC
Acmi-Circon Corporation
Gastroenterology & Urology · 28d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
K012712 · MLO
Norav Medical , Ltd.
Cardiovascular · 267d
Cleared May 08, 2002
COMPRESSIBLE LIMB SLEEVE
K012979 · JOW
Medical Device Services, Inc.
Cardiovascular · 245d
Cleared May 08, 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376 · DPW
Hemedex Incorporated
Cardiovascular · 209d
Cleared May 08, 2002
MICROJET CRONO PCA
K013822 · MEA
Cane S.R.L.
General Hospital · 173d
Cleared May 08, 2002
PADPRO MODEL #2516
K020203 · MKJ
Padpro, LLC
Cardiovascular · 106d
Cleared May 08, 2002
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD
K020313 · DKZ
Acon Laboratories Co.
Toxicology · 98d
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared May 08, 2002
HEC 1000
K020466 · KPJ
Metro Medical Equipment, Inc.
General & Plastic Surgery · 85d
Cleared May 08, 2002
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · DXE
Atrium Medical Corp.
Cardiovascular · 70d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · JIT
Dade Behring, Inc.
Chemistry · 63d