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
137329–137352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1988
NAMIC ANGIOGRAPHIC SYRINGE
K873955 · DXT
North American Instrument Corp.
Cardiovascular · 130d
Cleared Feb 05, 1988
IRAS EDS INTERFEROMETRIC STIMULATOR
K873990 · HLX
Randwal Instrument Co., Inc.
Ophthalmic · 127d
Cleared Feb 05, 1988
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · DQK
Hewlett-Packard Co.
Cardiovascular · 115d
Cleared Feb 05, 1988
BIOTIS (TM) HAEMOPHILUS DUCREYI
K874176 · JSJ
Otisville Biopharm, Inc.
Microbiology · 115d
Cleared Feb 05, 1988
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
K874338 · DSK
A&D Engineering, Inc.
Cardiovascular · 107d
Cleared Feb 05, 1988
BELLA - VAC IRRIGATOR
K874493 · KQT
Bel-Can Industries
Gastroenterology & Urology · 95d
Cleared Feb 05, 1988
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
K874681 · HQG
Klockner Contract Packaging, Inc.
Ophthalmic · 84d
Cleared Feb 05, 1988
ORTHODERM THERAPY BED
K874801 · FNM
Health Products, Inc.
General Hospital · 74d
Cleared Feb 05, 1988
MODEL 5202 MICROMANIPULATOR
K874811 · GEX
Coherent Medical Group
General & Plastic Surgery · 77d
Cleared Feb 05, 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · DQO
Target Therapeutics
Cardiovascular · 77d
Cleared Feb 05, 1988
POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
K874852 · DWF
Polystan C/O Vitalcor, Inc.
Cardiovascular · 72d
Cleared Feb 05, 1988
POLYSTAN TWO STAGE CATHETERS
K874853 · DWF
Polystan C/O Vitalcor, Inc.
Cardiovascular · 72d
Cleared Feb 05, 1988
LAWRENCE L3000 CARDIAC OUTPUT MONITOR
K874885 · DPW
Lawrence Medical Systems, Inc.
Cardiovascular · 66d
Cleared Feb 05, 1988
CARDIOVASCULAR SURGICAL INSTRUMENTS
K874960 · DWS
Solway, Inc.
Cardiovascular · 65d
Cleared Feb 05, 1988
ANOMALOSCOPE PLATE TEST - 5 [APT-5]
K875026 · HIT
Lkc Technologies, Inc.
Ophthalmic · 60d
Cleared Feb 05, 1988
NEW MODEL MB-550 BLOOD PRESSURE MONITOR
K875093 · DXN
Sharp Electronics Corp.
Cardiovascular · 57d
Cleared Feb 05, 1988
MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT
K875369 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 05, 1988
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
K880274 · HNR
Advanced Surgical Products, Inc.
Ophthalmic · 15d
Cleared Feb 04, 1988
TED MODEL 760
K871828 · CCK
Teledyne, Inc.
Anesthesiology · 269d
Cleared Feb 04, 1988
A-V RECORDER
K873041 · DPT
Life Sciences Manufacturing, Inc.
Cardiovascular · 184d
Cleared Feb 04, 1988
AEROBICA - LUNG EXERCISER
K873540 · BWF
MBA Healthcare Products, Inc.
Anesthesiology · 156d
Cleared Feb 04, 1988
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
K874298 · HBL
Engineered Orthopedic Technologies, Inc.
Neurology · 107d
Cleared Feb 04, 1988
HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
K874429 · GIQ
Hf Scientific, Inc.
Hematology · 99d
Cleared Feb 04, 1988
THROMBOPLASTIN.C
K874592 · GJS
Baxter Healthcare Corp
Hematology · 87d