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
147121–147144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1985
SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS
K843821 · CAC
Solco Basle, Inc.
Anesthesiology · 368d
Cleared Oct 01, 1985
EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN
K844776 · CCW
Medical Instruments and Lamps
Anesthesiology · 295d
Cleared Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · CFH
Helena Laboratories
Chemistry · 118d
Cleared Oct 01, 1985
LASERSAFE PERSONNEL AND PATIENT SHIELDS
K852405 · CAI
Lasersafe, Inc.
Anesthesiology · 117d
Cleared Oct 01, 1985
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
K852708 · DTB
Telectronics, Inc.
Cardiovascular · 97d
Cleared Oct 01, 1985
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
K853171 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 63d
Cleared Oct 01, 1985
BETA-HCG MICROTITER PREGNANCY TEST
K853258 · JHI
Modern Diagnostics, Inc.
Chemistry · 60d
Cleared Oct 01, 1985
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
K853345 · BWC
31st. Centruy Medical Corp.
Anesthesiology · 50d
Cleared Oct 01, 1985
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
K853391 · JJE
Eiken Chemical Co., Inc.
Chemistry · 49d
Cleared Oct 01, 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Oct 01, 1985
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K853502 · BTR
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Oct 01, 1985
FLOURESCENT T12 UVA TANNING LAMP
K853545 · FTC
Light Sources, Inc.
General & Plastic Surgery · 36d
Cleared Oct 01, 1985
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C
K853587 · FTC
Uvatan Industries , Ltd.
General & Plastic Surgery · 34d
Cleared Oct 01, 1985
SUNJET MODELS 240/280
K853679 · FTC
Sunjet Manufacturer, Inc.
General & Plastic Surgery · 27d
Cleared Oct 01, 1985
SUN TANNING BED MODEL EC-3RF
K853692 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 27d
Cleared Oct 01, 1985
VENTRESCREEN HCG URINE
K853748 · JHI
Vxr, Inc.
Chemistry · 22d
Cleared Oct 01, 1985
EMIT QST CARBAMAZEPINE ASSAY
K853835 · KLT
Syva Co.
Toxicology · 15d
Cleared Sep 30, 1985
THERMO SHORTWAVE DIATHERMY
K852166 · IMJ
Zimmer Elektromedizin GmbH
Physical Medicine · 133d
Cleared Sep 30, 1985
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)
K852411 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 116d
Cleared Sep 30, 1985
LODE COAGULOMETER MODEL LC-6
K852450 · JPA
Lode Corp.
Hematology · 112d
Cleared Sep 30, 1985
LKB 4057 ULTROSPEC II E
K852538 · JJQ
Lkb Instruments, Inc.
Chemistry · 144d
Cleared Sep 30, 1985
THERA-TRONIC THERAPEUTIC TREATMENT TABLE
K852651 · INQ
Rwm Co.
Physical Medicine · 101d
Cleared Sep 30, 1985
PORTALASE 200 CARBON SURGICAL LASER SYSTEM
K852694 · HHR
Minnesota Laser Corp.
Obstetrics & Gynecology · 96d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-80
K852698 · KFM
Bio Medicus, Inc.
Cardiovascular · 96d