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

Filters: Cleared only ×
176,076 results
158833–158856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1983
COMMUNITRACH TUBE
K823291 · BTO
Implant Technology, Inc.
Anesthesiology · 64d
Cleared Jan 08, 1983
TENS MAX
K823388 · GFK
Fujisawa Electronics Co.
Hematology · 54d
Cleared Jan 08, 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452 · DTB
Telectronics, Inc.
Cardiovascular · 52d
Cleared Jan 08, 1983
ERG-JET ELECTRODE
K823767 · HLF
Life-Tech Intl., Inc.
Ophthalmic · 25d
Cleared Jan 08, 1983
CLIRANS TE08 HOLLOW FIBER DIALYZER
K823768 · HRN
Terumo Medical Corp.
Ophthalmic · 25d
Cleared Jan 07, 1983
RAPID BACTERIURIA SCREENING TEST
K820126 · JXA
Analytical Luminescence Laboratory, Inc.
Microbiology · 354d
Cleared Jan 07, 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · KKX
W.L. Gore & Associates, Inc.
General Hospital · 128d
Cleared Jan 07, 1983
101M IN-THE-EAR
K823073 · ESD
Danavox, Inc.
Ear, Nose, Throat · 80d
Cleared Jan 07, 1983
SPUNGUARD FACE MASK
K823078 · FXX
Kimberly-Clark Corp.
General Hospital · 80d
Cleared Jan 07, 1983
SAY
K823118 · ESE
Kells Medical, Inc.
Ear, Nose, Throat · 78d
Cleared Jan 07, 1983
TEL-STAR NU-WAY & GENERIC E
K823178 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 73d
Cleared Jan 07, 1983
ESTROCEPT STABILIZED ESTROGEN RECEPTOR
K823186 · JJX
Brl
Chemistry · 73d
Cleared Jan 07, 1983
INTERFACE TRANSFUSION BLOOD FILTER #30
K823261 · CAK
Medical, Inc.
General Hospital · 66d
Cleared Jan 07, 1983
COBE HEMOCONCENTRATOR 1.3
K823338 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 60d
Cleared Jan 07, 1983
INSTRA-SAFE
K823430 · FSM
Instranetics, Inc.
General & Plastic Surgery · 52d
Cleared Jan 07, 1983
BIRT-A-SWITCH DSP #712
K823491 · GEI
Birtcher Corp.
General & Plastic Surgery · 45d
Cleared Jan 07, 1983
WRIGHT CARE
K823497 · GZJ
Dow Corning Wright
Neurology · 45d
Cleared Jan 07, 1983
CENTRAL SUPPLY ROOM WRAP
K823513 · FRG
James River Corp.
General Hospital · 39d
Cleared Jan 07, 1983
CK-ISOZYME U.V. REAGENT SET
K823550 · JHT
Gelman Sciences, Inc.
Chemistry · 38d
Cleared Jan 07, 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561 · FAP
Nihon Kohden America, Inc.
Gastroenterology & Urology · 36d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CREATININE
K823572 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CREATININE
K823573 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
K823574 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d