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

Filters: Cleared only ×
175,820 results
148201–148224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1985
BLHI LUTEINIZING HORMONE
K851332 · CEP
Euro-Diagnostics BV
Chemistry · 96d
Cleared Jul 09, 1985
AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS
K851548 · INM
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
MERIVAARA GERIATRIC CHAIR
K851550 · INM
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
MERIUAARA & ERACARE WHEELCHAIRS
K851553 · IOR
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
TMX-70 TREADMILL
K851629 · IOL
Eaton Medical Group
Physical Medicine · 82d
Cleared Jul 09, 1985
TMX-80 TREADMILL
K851630 · IOL
Eaton Medical Group
Physical Medicine · 82d
Cleared Jul 09, 1985
NYHUS/NELSON TUBE
K851672 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1985
27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
K851786 · LGG
Artiberia
Orthopedic · 75d
Cleared Jul 09, 1985
WHEELCHAIR CUSHIONS
K851814 · KIC
Dignicare
Physical Medicine · 74d
Cleared Jul 09, 1985
CURING LIGHT
K851915 · EBZ
Technology, Inc.
Dental · 69d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016 · KRY
R&D Systems, Inc.
Hematology · 61d
Cleared Jul 09, 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Jul 09, 1985
LEE-BEAD TSH(EIA)
K852224 · JLW
Lecco Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 09, 1985
DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)
K852280 · KKX
Outpatient Products Co.
General Hospital · 41d
Cleared Jul 09, 1985
DADE BLOOD GAS AMPUL INJECTOR
K852285 · JQW
American Dade
Chemistry · 41d
Cleared Jul 09, 1985
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
K852286 · JHJ
Sero-Immuno Diagnostics, Inc.
Chemistry · 41d
Cleared Jul 09, 1985
TERUMO SENSIBEAD EIA HGH KIT
K852299 · CFL
Terumo Medical Corp.
Chemistry · 41d
Cleared Jul 09, 1985
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Jul 09, 1985
DIG RADIOIMMUNOASSAY TEST SYSTEM
K852343 · DNL
M Nobird, Inc.
Toxicology · 36d
Cleared Jul 09, 1985
SIMULTANEOUS LH/FSH SYSTEM BY RIA
K852376 · CEP
American Bioclinical, Inc.
Chemistry · 35d
Cleared Jul 09, 1985
DERM-KIT
K852480 · JSI
Culture Kits, Inc.
Microbiology · 28d
Cleared Jul 09, 1985
3M FUKUDA TYPE RING RETRACTOR
K852567 · GAD
3M Company
General & Plastic Surgery · 21d
Cleared Jul 09, 1985
RUBIN DISPOSABLE CARTILAGE PLANNER
K852577
Frank F. Rubin
General & Plastic Surgery · 21d
Cleared Jul 09, 1985
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d