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
141289–141312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1987
PHONIC EAR MODELS PE 811CS AND PE 811CST
K864672 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Feb 20, 1987
A-TENS - MODEL AI-87
K864735 · GZJ
American Imex
Neurology · 78d
Cleared Feb 20, 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · JFJ
Data Medical Associates, Inc.
Chemistry · 73d
Cleared Feb 20, 1987
OLYMPUS PK300
K864834 · JJF
Olympus Corp.
Chemistry · 73d
Cleared Feb 20, 1987
REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
K864862 · JGS
Hf Scientific, Inc.
Chemistry · 71d
Cleared Feb 20, 1987
API UNISCEPT (TM) KB
K864891 · JWY
Analytical Products, Inc.
Microbiology · 67d
Cleared Feb 20, 1987
MEDICOMP INHALANT MASK ELBOW
K864896 · BZA
Medicomp, Inc.
Anesthesiology · 67d
Cleared Feb 20, 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · DQO
NuMED, Inc.
Cardiovascular · 65d
Cleared Feb 20, 1987
ACCUPOINT TOXO
K865068 · LGD
Syva Co.
Microbiology · 53d
Cleared Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · CDT
Sigma Diagnostics, Inc.
Chemistry · 49d
Cleared Feb 20, 1987
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
K870073 · DTL
Clinical Connections, Inc.
Cardiovascular · 43d
Cleared Feb 20, 1987
DIGILAB MODEL 1500 PERIMETER
K870120 · HPT
Bio-Rad
Ophthalmic · 39d
Cleared Feb 20, 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121 · HKX
Bio-Rad
Ophthalmic · 39d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 20, 1987
ENDOMYOCARDIAL BIOPSY DEVICE
K870186 · DWZ
Mansfield Scientific, Inc.
Cardiovascular · 35d
Cleared Feb 20, 1987
UNITED SURGICAL CORP. DIATHERMIC PLUS
K870194 · HQR
United Surgical Corp.
Ophthalmic · 31d
Cleared Feb 20, 1987
UNITED SURGICAL CORP. CRYOPTIC PLUS
K870195 · HPS
United Surgical Corp.
Ophthalmic · 31d
Cleared Feb 20, 1987
CRYSTAL MASK
K870206 · BYG
Brunswick Mfg. Co., Inc.
Anesthesiology · 31d
Cleared Feb 20, 1987
ARTHROSCOPIC SHOULDER HOLDER
K870212 · HST
Dyonics, Inc.
Neurology · 31d
Cleared Feb 20, 1987
COMPRESS AND SKULLCAP, HEAD DRESSING
K870240 · EXR
Fraass Survival Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 20, 1987
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET
K870252 · JJY
Casco Standards
Chemistry · 30d
Cleared Feb 20, 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · KYB
CooperVision, Inc.
Ophthalmic · 28d
Cleared Feb 20, 1987
CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695
K870278 · LPN
Ryder Intl. Corp.
Ophthalmic · 24d
Cleared Feb 20, 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d