FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159745–159768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1982
DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT
K821852
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Jul 02, 1982
VISCO HANDEX-VARIOUS MODELS
K821855 · ION
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-2082 FOLDING STOCKING AID
K821856 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-5305 MULTIPLE HAND GRID
K821857 · ION
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
NOTIE STRETCH-LACE-VARIOUS MODELS
K821858 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
ORTHOLACE 4,5.6 EYELET
K821859 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-6477 THE DERBY RAISED TOILET SEAT
K821860 · ILS
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A
K827375
Cranbury Medical Labs, Inc.
Radiology · 80d
Cleared Jul 02, 1982
BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800
K827376
Cranbury Medical Labs, Inc.
Radiology · 80d
Cleared Jul 02, 1982
ULTRASONIC CLEANER
K827508
Keymed House
Radiology · 81d
Cleared Jul 02, 1982
ADAC MODEL DPS-3300 DIGITAL PROCESSING SYSTEM
K827580
Adac Laboratories
Radiology · 18d
Cleared Jul 02, 1982
ADAC MODEL DPS-2800 DIGITAL PROCESSING SYSTEM
K827581
Adac Laboratories
Radiology · 18d
Cleared Jul 01, 1982
BX-1000 ISOMATIC
K820080 · IPF
Bloomex International, Inc.
Physical Medicine · 170d
Cleared Jul 01, 1982
ELECTRONIC MUSCLE EXERCISER
K821110 · IPF
Bloomex International, Inc.
Physical Medicine · 72d
Cleared Jun 30, 1982
CARD U.V. GERMICIDAL CHAMBER II
K820546 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 120d
Cleared Jun 29, 1982
LAURE WRIST IMPLANT
K803031 · KWM
Laure Prosthetics, Inc.
Orthopedic · 578d
Cleared Jun 29, 1982
ARTERIAL BLOOD FILTER, #AF-1025
K820044 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 173d
Cleared Jun 29, 1982
ENGSTOM EDITH
K821365 · BYD
Lkb Instruments, Inc.
Anesthesiology · 53d
Cleared Jun 29, 1982
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
K821376 · CBK
Ohio Medical Products
Anesthesiology · 50d
Cleared Jun 29, 1982
OPHTHALMIC EYEWEAR
K821391 · HQZ
Nordic Eyewear, Inc.
Ophthalmic · 49d
Cleared Jun 29, 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · CAD
Draeger Medical, Inc.
Anesthesiology · 25d
Cleared Jun 29, 1982
DISPOSABLE INTRAVENOUS INJECTION SYSTEM
K821764 · FPA
Medical Systems Research
General Hospital · 20d
Cleared Jun 28, 1982
IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
K827370
Irex Corp.
Radiology · 77d
Cleared Jun 25, 1982
MEDILAC #SR4 & SR 40
K820256 · DSH
Spelna, Inc.
Cardiovascular · 147d