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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
171241–171264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1978
MONITOR, GRAVITY IRRIGATION DRIP
K781717 · FLN
Syntel, Inc.
General Hospital · 16d
Cleared Oct 27, 1978
KENDRICK EXTRICATION DEVICE
K781761 · IQF
Medi-Ked, Inc.
Physical Medicine · 11d
Cleared Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · DTB
Pacesetter Systems
Cardiovascular · 14d
Cleared Oct 26, 1978
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2
K781552 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2
K781553 · CAC
Sorensen Research
Anesthesiology · 44d
Cleared Oct 26, 1978
FILTER, ARTERIAL BLOOD W/TUBING BYPASS
K781707 · DTM
Surgikos, Inc.
Cardiovascular · 16d
Cleared Oct 25, 1978
INTRA-ALERT
K781297 · FLN
Pan-Tech Research, Inc.
General Hospital · 90d
Cleared Oct 24, 1978
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K780958 · JTZ
Pittsburgh Micro-Media, Inc.
Microbiology · 134d
Cleared Oct 24, 1978
MUELLER HINTON AGAR WITH THYMIDINE
K780959 · JTZ
Pittsburgh Micro-Media, Inc.
Microbiology · 134d
Cleared Oct 24, 1978
DIALYSIS SYS., PDS 400 & RO 400
K781156 · DJC
Physio-Control Corp.
Toxicology · 105d
Cleared Oct 24, 1978
CENTRAL CATHETER TRAY
K781333 · KGC
Argon Medical Corp.
Gastroenterology & Urology · 83d
Cleared Oct 24, 1978
CYTOMEGILISH TEST KIT
K781392 · GOK
Microbiological Assoc.
Microbiology · 75d
Cleared Oct 24, 1978
BAYLOW VISUAL ACUITY TESTER
K781452 · HOX
Codman & Shurtleff, Inc.
Ophthalmic · 62d
Cleared Oct 24, 1978
MODEL 770 ARGON LASER
K781453 · GEX
Spectra-Physics, Inc.
General & Plastic Surgery · 63d
Cleared Oct 24, 1978
MONOJECT SCALE MAGNIFIER
K781459 · HJY
Sherwood Medical Industries
Ophthalmic · 62d
Cleared Oct 24, 1978
DISPOSABLE LECTROSWITCH, MODEL E2503
K781510 · GEI
Valleylab, Inc.
General & Plastic Surgery · 53d
Cleared Oct 24, 1978
LECTROSWITCH MODEL E2502B
K781511 · GEI
Valleylab, Inc.
General & Plastic Surgery · 53d
Cleared Oct 24, 1978
SURG-O-PAK PREP PAD
K781534 · KKX
Convertors
General Hospital · 48d
Cleared Oct 24, 1978
ORBIOGRAPH
K781543 · HLT
Sonometrics Systems, Inc.
Ophthalmic · 46d
Cleared Oct 24, 1978
MICROSURGURY VISIBILITY BACKGROUND
K781547
Ethicon, Inc.
General & Plastic Surgery · 41d
Cleared Oct 24, 1978
ALKALINE PHOSPHATASE IN SERUM
K781609 · CJE
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Oct 24, 1978
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · CIG
Fisher Scientific Co., LLC
Chemistry · 35d