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
143737–143760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 29, 1986
GENTAMICIN-50MG/ML
K861869 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER
K861870 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
NCTC 109 MEDIUM
K861871 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM
K861872 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
MEM GLASGOW MEDIUM
K861873 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER
K861874 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER
K861875 · KIT
Hazleton Research Products, Inc.
Pathology · 14d
Cleared May 29, 1986
CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
K861879 · CGS
Hi Chem, Inc.
Chemistry · 14d
Cleared May 29, 1986
WILLIAMS MEDIUM E POWDER
K861885 · KIT
Hazleton Research Products, Inc.
Pathology · 13d
Cleared May 29, 1986
DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM
K861886 · KIT
Hazleton Research Products, Inc.
Pathology · 13d
Cleared May 29, 1986
MEM GLASGOW POWDERED MEDIUM
K861887 · KIT
Hazleton Research Products, Inc.
Pathology · 13d
Cleared May 29, 1986
RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T
K861940 · IZZ
D&R X-Ray Products, Inc.
Radiology · 9d
Cleared May 28, 1986
CAROTID BALLOON SHUNT
K860497 · DWF
Imodex, Inc.
Cardiovascular · 107d
Cleared May 28, 1986
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
K860573 · DXY
Telectronics, Inc.
Cardiovascular · 103d