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
149737–149760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1985
ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM
K850533 · FPA
Atlantic Optical Systems, Inc.
General Hospital · 38d
Cleared Mar 21, 1985
ARGYLE 15MM SWIVEL CONNECTOR
K850625 · BZA
Sherwood Medical Co.
Anesthesiology · 30d
Cleared Mar 21, 1985
NASOPHARYNGEAL AIRWAY-ROBERTAZZI
K850644 · BTQ
Dryden Corp.
Anesthesiology · 30d
Cleared Mar 21, 1985
ENCORE FERRITIN REAGENT
K850680 · JMB
Hybritech, Inc.
Chemistry · 28d
Cleared Mar 21, 1985
PAD, PRE-OPERATIVE PREPARATION
K850811 · KME
East Texas Lighthouse For the Blind
General Hospital · 21d
Cleared Mar 21, 1985
ACTH II BY RADIOIMMUNOASSAY
K850882 · CKG
Immuno Nuclear Corp.
Chemistry · 17d
Cleared Mar 21, 1985
OPHTHALMIC DROPPER BOTTLES
K850962
Acacia, Inc.
Ophthalmic · 13d
Cleared Mar 21, 1985
ELECTRIC LIFT TABLE-OPHTHALMIC
K851008
Turbine Support Systems, Inc.
Ophthalmic · 9d
Cleared Mar 20, 1985
VISOPROTECT OCCULAR SHIELD
K850005 · HMP
M.S.G. Health Systems, Inc.
General & Plastic Surgery · 77d
Cleared Mar 20, 1985
VISOPROTECT: OCCULAR SHIELD
K850099 · HMP
Rockway Enterprises, Inc.
General & Plastic Surgery · 68d
Cleared Mar 20, 1985
FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
K850127 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 20, 1985
C.N.V.T.
K850299 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
MUCOLYSE
K850300 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
YEAST DIALYSATE
K850301 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
CAMPYLOBACTER SUPPLEMENT -SKIRROW
K850306 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG
K850307 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
C.L.A.T.
K850308 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
AMDINOCILLIN 10 MCG SENSI-DISC
K850357 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 49d
Cleared Mar 20, 1985
CEFTRIAXONE 30 MCG SENSI-DISC
K850358 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 49d
Cleared Mar 20, 1985
CELL CULTURE REFEED MEDIUM
K850537 · KIT
Hillcrest Biologicals
Pathology · 37d
Cleared Mar 20, 1985
AMDINOCILLIN 10 MCG SENSITIVITY DISCS
K850607 · JTN
Difco Laboratories, Inc.
Microbiology · 33d
Cleared Mar 20, 1985
SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
K850636 · KDX
Fisher Scientific Co., LLC
Pathology · 29d
Cleared Mar 20, 1985
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE
K850658 · JSG
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Mar 20, 1985
CORNEASCOPE MODEL 1200
K850665 · HLQ
Kera Corp.
Ophthalmic · 28d