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
148849–148872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1985
LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20
K851292 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 52d
Cleared May 23, 1985
COMFORT-EASE ELECTRODE
K851303 · GXY
Medtronic Vascular
Neurology · 52d
Cleared May 23, 1985
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
K851385 · JOL
Gesco Intl., Inc.
General Hospital · 44d
Cleared May 23, 1985
BARD PERISTOMAL PASTE
K851398 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared May 23, 1985
OLBERT CATHETER SYS FOR URETERAL DILATION
K851463 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 38d
Cleared May 23, 1985
OPTHALMIC BAR PRISM
K851555 · HKW
Roseburg SA
Ophthalmic · 37d
Cleared May 23, 1985
VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
K851653 · KPQ
Varian Assoc., Inc.
Radiology · 31d
Cleared May 23, 1985
CAPNOMED
K851658 · CCK
Draeger Medical, Inc.
Anesthesiology · 30d
Cleared May 23, 1985
OMNIMED SUPERIOR TRANSDUCER PROTECTOR
K851734 · FIB
Omni Intl., Inc.
Gastroenterology & Urology · 28d
Cleared May 23, 1985
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
K851790 · HNN
Artiberia
Ophthalmic · 28d
Cleared May 23, 1985
53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
K851797 · FFQ
Artiberia
Gastroenterology & Urology · 28d
Cleared May 23, 1985
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · KNW
Artiberia
Gastroenterology & Urology · 28d
Cleared May 23, 1985
TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
K851856 · CBI
Sheridan Catheter Corp.
Anesthesiology · 27d
Cleared May 23, 1985
COMPRESSED AIR CONNECTOR DISPOSABLE CONNECTOR
K851920
Dhd Medical Products Div. Diemolding...
Cardiovascular · 21d
Cleared May 23, 1985
STOPCOCKS
K851986 · FMG
Transamerica Delaval, Inc.
General Hospital · 16d
Cleared May 22, 1985
AMPCO OPTHALMIC TRAY
K842983 · HOZ
Associated Medical Products Co.
Ophthalmic · 296d
Cleared May 22, 1985
SONOMED TECH OPHTHALMIC B-SCAN B-3000
K844031 · ITX
Sonomed Technology, Inc.
Radiology · 219d
Cleared May 22, 1985
MTA 86
K844592
Madsen Electronics (Canada) , Ltd.
Neurology · 177d
Cleared May 22, 1985
EYE PROCEDURE PACK
K850340 · HOZ
Marwood Medical, Inc.
Ophthalmic · 114d
Cleared May 22, 1985
PMS AMNIOCENTESIS TRAY/KIT
K850632 · HIO
Professional Medical Services
Obstetrics & Gynecology · 92d
Cleared May 22, 1985
DENTAL ACRYLIC POLYMERS
K850650 · EBI
Cole Polymers , Ltd.
Dental · 92d
Cleared May 22, 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · KNS
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared May 22, 1985
CODMAN ARTHROSCOPE
K851229 · HRX
Codman & Shurtleff, Inc.
Orthopedic · 57d
Cleared May 22, 1985
RMC POSTERIOR STABILIZED KNEE SYSTEM
K851231 · JWH
Richards Medical Co., Inc.
Orthopedic · 57d