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
141217–141240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1987
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
K862820 · GWM
Ladd Research Industries, Inc.
Neurology · 216d
Cleared Feb 26, 1987
IUC - INTRAUTERINE CATHETER
K862873 · KXO
Utah Medical Products, Inc.
Obstetrics & Gynecology · 211d
Cleared Feb 26, 1987
CPREVIVER
K864125 · BTM
Augerscope, Inc.
Anesthesiology · 128d
Cleared Feb 26, 1987
SCHULDT* PLUS 8 T.E.N.S. DEVICE
K864368 · GZJ
Schuldt Laboratories, Inc.
Neurology · 113d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · GTY
Abbott Laboratories
Microbiology · 83d
Cleared Feb 26, 1987
VIEW(TM) IMAGE PROCESSING AND VIEWING STATION
K864854 · LLZ
Virtual Imaging
Radiology · 77d
Cleared Feb 26, 1987
IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
K865027 · MOT
Cis-Us, Inc.
Radiology · 65d
Cleared Feb 26, 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · GZJ
Medtronic Vascular
Neurology · 64d
Cleared Feb 26, 1987
STIMUTRON MODEL 100
K865054 · IPF
The Austin-Lenick Co.
Physical Medicine · 64d
Cleared Feb 26, 1987
FERRAY EXTRACTOR
K870083 · HWB
Terray Manufacturing, Inc.
Orthopedic · 49d
Cleared Feb 26, 1987
REDMAN ACCESSORIES
K870298 · KNO
Redman, Inc.
Physical Medicine · 29d
Cleared Feb 26, 1987
RUBYCELL(TM) SYNTHETIC ISLAND DRESSING
K870352 · FRO
Bioderm, Inc.
General & Plastic Surgery · 28d
Cleared Feb 26, 1987
ISE COMPENSATION SERA
K870379 · JIS
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 26, 1987
GAUZE, ABSORBENT, IODOFORM IMPREGNATED
K870431 · FRO
Steridyne Laboratories, Inc.
General & Plastic Surgery · 23d
Cleared Feb 26, 1987
SPOTTEST PYR REAGENT
K870449 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Feb 26, 1987
QUICKIE RX PRESCRIPTION WHEELCHAIR
K870476 · IOR
Motion Designs, Inc.
Physical Medicine · 23d
Cleared Feb 26, 1987
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
K870502 · JSI
Clinical Convenience Products, Inc.
Microbiology · 22d
Cleared Feb 26, 1987
DANNIFLEX 400I
K870510 · BXB
Buckman Co., Inc.
Physical Medicine · 21d
Cleared Feb 26, 1987
KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L
K870565 · JAC
Eastman Kodak Company
Radiology · 16d
Cleared Feb 26, 1987
ELEVATOR, COBB SPINAL
K870591 · GEG
Military Engineering, Inc.
General & Plastic Surgery · 16d
Cleared Feb 26, 1987
KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL
K870701 · JAC
Eastman Kodak Company
Radiology · 6d
Cleared Feb 26, 1987
SKAN D-SCOPE
K870703 · IYX
Medx, Inc.
Radiology · 6d
Cleared Feb 25, 1987
DOPPLER UNIT, SDS-100A
K863577 · IYN
Toshiba Medical Systems
Radiology · 166d
Cleared Feb 25, 1987
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22
K863609 · FKP
International Medical Products, Inc.
Gastroenterology & Urology · 162d