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
148537–148560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1985
MICRO-INHALER MODEL TV-7000 & TV-8000
K851254 · CCQ
Bioclimatic, Inc.
Anesthesiology · 82d
Cleared Jun 18, 1985
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · KWA
Osteonics Corp.
Orthopedic · 70d
Cleared Jun 18, 1985
NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
K851981 · FOZ
Superior Plastic Products Corp.
General Hospital · 42d
Cleared Jun 18, 1985
MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
K852105 · FCH
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 34d
Cleared Jun 18, 1985
NON-STERILE GAUZE ROLLER BANDAGES
K852265 · EFQ
Leonard Joseph Co.
General & Plastic Surgery · 25d
Cleared Jun 18, 1985
ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES
K852267 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 21d
Cleared Jun 18, 1985
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
K852334 · HLJ
Design Med. Corp.
Ophthalmic · 18d
Cleared Jun 18, 1985
LIDGRER-LUND ACETABULAR SOCKETS
K852369 · JDL
Link America, Inc.
Orthopedic · 14d
Cleared Jun 17, 1985
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
K850144 · FRC
American Sterilizer Co.
General Hospital · 154d
Cleared Jun 17, 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · KHE
Nms Pharmaceuticals, Inc.
Hematology · 133d
Cleared Jun 17, 1985
HOME BILI LIGHTS-MODEL 100
K850599 · LBI
Physician Engineered Products, Inc.
General Hospital · 122d
Cleared Jun 17, 1985
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
K851285 · DCF
Cooper Biomedical, Inc.
Immunology · 77d
Cleared Jun 17, 1985
FORTUNA DISPOSABLE SYRINGES
K851519 · FMF
Impor-Tex, Intl., Inc.
General Hospital · 63d
Cleared Jun 17, 1985
TROCAR CATHETER
K851979 · JOL
Hospital Products Group
General Hospital · 41d
Cleared Jun 17, 1985
DEKNATEL THORACIC CATHETER
K852041 · JOL
Pfizer, Inc.
General Hospital · 39d
Cleared Jun 17, 1985
MERIVAARA CRIB TROLLEY-MODEL 381
K852173 · FMS
Daun International, Inc.
General Hospital · 28d
Cleared Jun 14, 1985
AMBULATORY PH RECORDING DEVICE
K842349 · DSH
Clinical Data Instruments, Inc.
Cardiovascular · 364d
Cleared Jun 14, 1985
PHOENIX ANESTHESIA MACHINE
K844563 · BSZ
American Anesthesia, Inc.
Anesthesiology · 205d
Cleared Jun 14, 1985
RESP-BAC BACTERIA FILTER
K851070 · CAH
Medicomp, Inc.
General Hospital · 88d
Cleared Jun 14, 1985
ANESTHESIA BREATHING CIRCUIT
K851193 · CAI
Avatron, Inc.
Anesthesiology · 80d
Cleared Jun 14, 1985
DESERET ARTERIAL CATHETER
K851327 · FOZ
Parke-Davis Co.
General Hospital · 71d
Cleared Jun 14, 1985
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K851479 · CAZ
Vygon Corp.
Anesthesiology · 60d
Cleared Jun 14, 1985
GASTROINTESTINAL TUBE
K851671 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 52d
Cleared Jun 14, 1985
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · JWM
Toshiba Medical Systems
Radiology · 52d