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
144313–144336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1986
TRYPSIN RIA KIT
K861097 · JNO
Microanalytic Research, Inc.
Chemistry · 66d
Cleared May 29, 1986
RAICHEM AMYLASE REAGENT
K861269 · JFJ
Reagents Applications, Inc.
Chemistry · 55d
Cleared May 29, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367 · KLS
Eastman Kodak Company
Chemistry · 48d
Cleared May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
K861393 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
OHMEDA 5300 ANESTHETIC AGENT MONITOR
K861397 · CBQ
Ohmeda Medical
Anesthesiology · 44d
Cleared May 29, 1986
ADAPTABLE CLASS III MASK
K861424 · DZB
Great Lakes Orthodontics, Ltd.
Dental · 43d
Cleared May 29, 1986
KINETIC ALKALINE PHOSPHATASE REAGENT KIT
K861638 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 29d
Cleared May 29, 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · HPX
Allergan, Inc.
Ophthalmic · 29d
Cleared May 29, 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · CIG
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
IRON PROCEDURE
K861652 · JIY
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
AST/GOT PROCEDURE
K861656 · CIT
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
CALCIUM PROCEDURE
K861657 · CIC
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ALT/GPT PROCEDURE
K861658 · CKA
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
LACTATE DEHYDROGENASE (LD) PROCEDURE
K861662 · CFJ
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667 · CJE
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K861672 · JPZ
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ACID PHOSPHATASE PROCEDURE
K861675 · CKB
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
WETTING & SOAKING HARD CONTACT LENS SOLUTION
K861712 · HPX
Maurry Biological Co.
Ophthalmic · 24d
Cleared May 29, 1986
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
K861718 · JFJ
Reagents Applications, Inc.
Chemistry · 28d
Cleared May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
K861750 · CFE
Helena Laboratories
Chemistry · 23d
Cleared May 29, 1986
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
K861835 · GTH
Syva Co.
Microbiology · 16d
Cleared May 29, 1986
MEM ALPHA EAGLE MEDIUM
K861867 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
WILLIAMS MEDIUM E
K861868 · KIT
Hazleton Research Products, Inc.
Pathology · 14d